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49th Annual Report 2014-15
OPPI 2015 Final AW 1st Part For Printing.indd 3 02/10/2015 3:59:38 PM
“I am proudthat together our
message of hopehas demonstrated
that one can gobeyond diabetes
and open thedoor to a life full
of possibilities.” Eshaan Shevate
(The youngest member of an international team of people
with Type 1 diabetes) participated in the Sanofi and
World Diabetes Tour’s ‘Type 1 Diabetes Challenge’ to
Machu Picchu, Peru in 2014.
SANOFI FOCUSED ON PATIENTS’ NEEDSSince 1956, Sanofi has aligned itself with India’s healthcare needs by building expertise, capability and capacity, through continued investments, strategic partnerships and a shared commitment towards patients.
www.sanofi.com www.sanofi.in www.sanofiindialtd.com
Through an integrated approach to diabetes
management - comprehensive portfolio, patient
support programme ‘Saath 7’; ‘Made in India’
reusable insulin pen AllStar™, public awareness
drives and ongoing scientific initiatives
- Sanofi endeavours to make a sustainable
difference to the diabetes ecosystem in India
- centered on patient needs.
OPPI 2015 Final AW 1st Part For Printing.indd 4 02/10/2015 3:59:39 PM
Content
ANNUAL REPORT 2014-15
Executive Committee and Members 01
Message from President 03
Message from Director General 05
Pharmaceutical Landscape 07
Reports:
l Working Groups 15
l Committees 21
Looking Back 27
Project Jawhar 31
Awards 33
Meetings with Policy Makers and Government Authorities 36
Representations 53
Seminars and Knowledge Programmes 64
Past Presidents 68
“I am proudthat together our
message of hopehas demonstrated
that one can gobeyond diabetes
and open thedoor to a life full
of possibilities.” Eshaan Shevate
(The youngest member of an international team of people
with Type 1 diabetes) participated in the Sanofi and
World Diabetes Tour’s ‘Type 1 Diabetes Challenge’ to
Machu Picchu, Peru in 2014.
SANOFI FOCUSED ON PATIENTS’ NEEDSSince 1956, Sanofi has aligned itself with India’s healthcare needs by building expertise, capability and capacity, through continued investments, strategic partnerships and a shared commitment towards patients.
www.sanofi.com www.sanofi.in www.sanofiindialtd.com
Through an integrated approach to diabetes
management - comprehensive portfolio, patient
support programme ‘Saath 7’; ‘Made in India’
reusable insulin pen AllStar™, public awareness
drives and ongoing scientific initiatives
- Sanofi endeavours to make a sustainable
difference to the diabetes ecosystem in India
- centered on patient needs.
OPPI 2015 Final AW 1st Part For Printing.indd 5 02/10/2015 3:59:39 PM
PRESIDENT
Dr Shailesh Ayyangar Sanofi India Ltd
VICE PRESIDENTS
Sudarshan Jain Abbott Healthcare Pvt Ltd
Sameer Savkur (up to 01.12.2014) Biogen Idec Biotech India Pvt Ltd
Aijaz Tobaccowalla Pfizer Ltd
K.G. Ananthakrishnan MSD Pharmaceuticals Pvt Ltd
Sharad Tyagi Boehringer Ingelheim India Pvt Ltd
MEMBERS
Raghu Kumar Allergan India Pvt Ltd
Sanjay Murdeshwar AstraZeneca Pharma India Ltd
Angel-Michael Evangelista Bayer Pharmaceuticals Pvt Ltd
Anish Bafna (up to 09.07.2015) Baxter India Ltd
Jitendra Tyagi Bristol-Myers Squibb India Pvt Ltd
K. Shivkumar (up to 31.03.2015) Eisai Pharmaceuticals India Pvt Ltd
Dr Sanjit Singh Lamba (w.e.f. 09.04.2015) Eisai Pharmaceuticals India Pvt Ltd
G. Sathya Narayanan Galderma India Pvt Ltd
Dr Hasit B. Joshipura (up to 31.07.2015) GlaxoSmithKline Pharmaceuticals Ltd
Sanjiv Navangul Johnson & Johnson Ltd
Ali Sleiman (w.e.f. 18.06.2015) Merck Ltd
Dr Ramesh Panchagnula Nektar Therapeutics (India) Pvt Ltd
Ranjit Shahani Novartis India Ltd
Melvin D’Souza Novo Nordisk India Pvt Ltd
Maturin Tchoumi Roche Products (India) Pvt Ltd
Aman Bajaaj Takeda Pharmaceuticals India Pvt Ltd
SPECIAL INVITEES
Annaswamy Vaidheesh (w.e.f. 20.08.2015) GlaxoSmithKline Pharmaceuticals Ltd
Arnaud Lefevre (w.e.f. 20.08.2015) UCB India Pvt Ltd
SECRETARIAT
MUMBAI Ranjana Smetacek Director General
Rajiv Shukla Director – Alliance Development
Vivek Padgaonkar Director – Project & Policy
Dr Ajaykumar Sharma Director – Research
Bhavna Singh Director – Communications
Ajit Bendre Director – Finance, Admn. & Association Secretary
Ashvin Muchhala Manager – Accounts & Administration
Cloti Baptista Sr. Executive Secretary
NEW DELHI Tabrez Ahmad Secretary General
Prem Singh Rawat Manager – Government Affairs
Executive Committee
01 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 1st Part For Printing.indd 6 02/10/2015 3:59:39 PM
ORDINARY MEMBERS:
• Abbott Healthcare Pvt Ltd • Allergan India Pvt Ltd • Amgen Technology Pvt Ltd • Astellas Pharma India Pvt
Ltd • AstraZeneca Pharma India Ltd • Bayer Pharmaceuticals Pvt Ltd • Bilcare Ltd • Boehringer Ingelheim
India Pvt Ltd • Bristol-Myers Squibb India Pvt Ltd • Dey’s Medical (U.P.) Pvt Ltd • Eisai Pharmaceuticals
India Pvt Ltd • Eli Lilly and Company (India) Pvt Ltd • Fresenius Kabi India Pvt Ltd • Galderma India Pvt Ltd
• GlaxoSmithKline Pharmaceuticals Ltd • GSI Pharma Pvt Ltd • Johnson & Johnson Ltd • Laboratoires Griffon
Ltd • Lundbeck India Pvt Ltd • Martin & Harris Pvt Ltd • Merck Ltd (Merck Serono) • MSD Pharmaceuticals Pvt
Ltd • Nektar Therapeutics (India) Pvt Ltd • Novartis India Ltd • Novo Nordisk India Pvt Ltd • Pfizer Ltd • Roche
Products (India) Pvt Ltd • Sanofi India Ltd • Serdia Pharmaceuticals (India) Pvt Ltd • Takeda Pharmaceuticals
India Pvt Ltd • UCB India Pvt Ltd
AFFILIATE MEMBERS:
• BMR & Associates LLP • Ernst & Young LLP • IMS Health Information & Consulting Services India Pvt Ltd
• KPMG in India • Quintiles Research (India) Ltd • Strategic Marketing Solutions and Research Centre Pvt Ltd
• Wolters Kluwer Health India Pvt Ltd • Yes Bank Ltd
ASSOCIATE MEMBERS:
• ACG Associated Capsules Pvt Ltd • SCHOTT Glass India Pvt Ltd
Members
1 The Associated Chambers of Commerce & Industry of India (ASSOCHAM), New Delhi
2. Confederation of Indian Industry (CII), New Delhi
3. Employers’ Federation of India (EFI), Mumbai
4. Federation of Indian Chambers of Commerce and Industry (FICCI), New Delhi
5. Indian Merchants’ Chambers (IMC), Mumbai
6. International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), Geneva, Switzerland
OPPI’S MEMBERSHIP OF ASSOCIATIONS:
02
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50 years ago India was just emerging from her past, striving to bring prosperity, progress and good health
to her people. The nascent pharmaceutical industry of India, at that time, became involved in building
manufacturing bases and quality systems to meet the growing need for medicines in the country. Half
a century ago, the formation of the Organisation of Pharmaceutical Producers of India (OPPI) signaled
the beginning of a golden era for the Indian Pharmaceutical Industry. Over these five decades we have
witnessed dramatic progress in our industry. Both domestic and multinational companies have played
a crucial role in creating a world-class image for our medicines – now being exported to every part of
the world. This industry stands tall alongside the Information Technology sector as the true ‘Pride of the
Nation’. The advancement in chemistry and process innovation in drug delivery systems has catapulted
India among the top exporting countries of quality medicines. OPPI salutes all the past colleagues in our
industry, who had the vision and courage to navigate through difficult times and the current workforce for
continuing to raise the bar!
Through the eventful 20th century, OPPI member companies helped create a strong industrial footprint in
India, which was reinforced by the visionaries of major domestic companies by creating their own industrial
facilities. As a result, India has attained near self-sufficiency in chemistry-based drug manufacturing and
has received international recognition as a leading exporter of quality finished formulations. It is a matter
of great pride that even today, some of the iconic brands prescribed by the medical fraternity in India have
come from the research platforms of OPPI member companies.
We have also witnessed major changes in the socio-economic milieu and in the demographic profile of
our country in the past 50 years. The disease pattern in India has been shifting. We have made good
progress in combating communicable diseases, albeit much still remains to be done, but the emergence of
Non-Communicable Diseases (NCDs) now poses a big challenge to the healthcare system. OPPI member
companies have played a leading role in bringing the fruits of years of research and development for the
benefit of Indian patients suffering from various NCDs. Today, as the world applauds the efforts made by
our Health Ministry in winning the war against Polio, it should be remembered with pride that OPPI member
companies have stood with the nation in making the Oral Polio Vaccine available to the children of India.
Our member companies are working with various state governments and the central government in the
DR SHAILESH AYYANGAR
President, OPPI
03 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 1st Part For Printing.indd 8 02/10/2015 3:59:39 PM
herculean task of enhancing awareness about NCDs, providing crucial lifesaving vaccines and engaging in
patient support programmes to help modify lifestyles.
Since its inception, OPPI has always stood for encouraging scientific quest, research and innovation. We
have steadfastly pursued this route against all odds and voices of dissent. We believe there can never be
any short-cuts in drug development as we deal with patients’ lives and safety. We cannot waiver from our
path of drug discovery research to find newer and safer medicines to help mankind. In the process, we
have helped the generic bio-pharmaceutical industry, because there would be few generics if there were
no research!
In hind sight, it would be fair to say that our successive Governments, during the past 50 years, should
have remained steadfast in allocating more resources for healthcare infrastructure capable of serving our
growing population. This has not happened for a variety of reasons and we remain among the lowest
ranked nations as far as public funding of the healthcare system is concerned. Almost seven decades post
independence, our public healthcare system remains unreliable and patchy in many states, and therefore
heavily dependent on private sector financing. Indeed, we have many challenges in our country but surely,
human health and dignity should have been the top priority! Having said this, much progress has been
made in recent years. Many healthcare indices look much better today as compared with 50 years ago. But
we have miles to go and much has to be done before we can achieve Health for All.
This past year, Government has taken some laudable steps, such as liberalising FDI in Brown field and
Green field pharmaceutical projects, developing a National Health Policy draft and stating their intention
to encourage R&D and implement IPR regulations in letter and spirit. The single window concept for
approvals of industrial sites in many states, the reopening of the Clinical Trials sector and the transparent
drug approval systems being put in place, are all very welcome moves. The Honourable Prime Minister,
Mr Narendra Modi, has often said that he would like to create an ecosystem of predictability and increase
ease of doing business in India. The industry is anticipating concrete actions in this regard, which will help
create more jobs, bring more investments in the sector and forge technological partnerships to leap-frog
in creating an inclusive healthcare system. I can say on behalf of OPPI member companies that we are
fully committed to working with our Government and all other stakeholders to ensure that healthcare for all
becomes a reality in the next decade.
On the eve of our Golden Jubilee anniversary, OPPI member companies rededicate themselves to the
task of achieving our national objective of Health for All. I thank all my fellow industry colleagues and all
stakeholders for their tremendous commitment and support over the past five decades.
04
Dr Shailesh AyyangarPresident, OPPIOctober 17, 2015 Mumbai
OPPI 2015 Final AW 1st Part For Printing.indd 9 02/10/2015 3:59:39 PM
India has all the knowledge, technologies and interventions required for providing quality healthcare
to her people, for both disease prevention and treatment. On the face of it, much of the ill health,
disease, premature death and suffering we see around us is avoidable. To quote the draft National Health
Policy 2015, “The reality is straightforward. The power of existing interventions is not matched by the
power of health systems to deliver them to those in greatest need, in a comprehensive way, and on an
adequate scale”.
The long-term solution to India’s healthcare challenges will require a holistic approach and a critical
evaluation of our existing systems. We must have sustainable policy solutions to address healthcare
financing, infrastructure and human resource challenges. We remain hopeful that Government will accord
priority to healthcare, increase healthcare budgets and implement the promised Universal Health Assurance
programme. The pharmaceutical industry remains passionate and committed to fulfilling its role in helping
to address the nation’s healthcare challenges.
Medicines are a critical component of healthcare and there is no question that all people should have access
to all medicines. OPPI stands for a collaborative approach that will ensure patients access to innovative
medicines while supporting growth for India, through research, innovation and manufacturing. The creation
of a healthy India requires balancing the need for innovation with the necessity for more affordable medicines,
within a robust IP environment. Pro-innovation policies and increased access to medicines must go hand-
in-hand for the benefit of our patients. We will need to Make, Develop and Innovate in India if we are to truly
become a ‘Pharmacy to the World’.
RANJANA SMETACEK
Director General, OPPI
05 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 1st Part For Printing.indd 10 02/10/2015 3:59:40 PM
All of us have a collective responsibility towards all patients and we must guarantee to deliver responsible
healthcare. This is possible only when our entire healthcare system complies with global good manufacturing
practices and stringent ethics codes. To this end, Government’s formalising of the Uniform Code of
Pharmaceuticals Marketing Practices (UCPMP) this year, is a very welcome move.
As OPPI celebrates 50 years of being, I ask you to celebrate with us. As an industry, we have much to be
proud of: the Indian pharmaceutical industry is the third largest in the world by volume; it is the second
highest foreign exchange earner in the world; and it is a generics powerhouse.
Today, we can look back at a glorious past that has seen dramatic improvement in the quality of life,
unprecedented longevity and cures for diseases that were once incurable! We continue to aspire to make
a difference and strive towards a better tomorrow. We look forward to seeing a ‘Healthy India and an
Innovative India’.
I thank all my members and well-wishers for their continuous support, as we remain committed to fulfilling
our collective dream of extending healthcare to all people across India.
Ranjana Smetacek Director General, OPPI October 17, 2015 Mumbai
06
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THE PHARMACEUTICAL LANDSCAPEIndia is the fifth fastest growing economy in the world (Source: Euromonitor) and is poised to become the third largest economy by 2040 (Source: PwC). A growing educated middle-class, rising income levels and increase in life expectancy are all indicators of a developing economy.
Unfortunately, rising affluence has also led to an increase in chronic and lifestyle-related diseases. However, growth in public expenditure on healthcare has not kept pace with the rapid growth of private and speciality hospitals, and the increased penetration of health insurance (which has a lot of space to grow even more).
Indian Pharmaceutical Industry India’s Life Sciences industry occupies a place of prominence globally. In pharmaceuticals, India is ranked eighth by value (USD 29 bn) and continues to enjoy high growth rates, between 15 per cent and 20 per cent, closely competing with China. Indian companies enjoy a strong presence in the US generics market, commanding a share of 19 per cent in 2014 as against 13 per cent in 20101.
Key Highlights of the Indian Pharmaceutical Industry2:
Domestic Pharmaceutical Formulation MarketThe domestic pharmaceutical formulation market has grown from USD 10.3 bn in 2010 to close to USD 15 bn in 2015. Historically, the Indian Pharmaceutical Market (IPM) has grown annually by twice the GDP growth percentage. It is now expected that the IPM will touch around USD 55 bn by 20204.
1 Indian Lifesciences 2030: Mckinsey-FICCI report | 2 IBEF Pharmaceuticals report 2015 | 3DIPP website | 4 IMS Institute Analysis
07 ANNUAL REPORT 2014-15
Leading pharmaceutical India’s pharmaceutical industry accounts for about 1.4 per cent producer of the global pharmaceutical industry in value terms, and 10 per cent by volume
One of the largest exporters India accounts for 20 per cent of global exports in generics
Among the fastest-growing The country’s pharmaceutical industry is expected to expand at industries a CAGR of 14.5 per cent over 2009-20, to $55 bn at the end of the period
Rapidly growing Healthcare, another fast-growing sector, is expected to grow at a healthcare sector CAGR of 17 per cent to $280 bn over 2011-20
Growing generics market The generic market is expected to grow to $26.1 bn by 2016 from $11.3 bn in 2011; India’s generics market has extraordinary potential for growth
Ranked 5th in terms of • Attracted 5 per cent of total FDI into India from attracting FDI April 2000 to June 20143
• Cumulative FDI inflows of $13.3 bn from April 2000 to June 20143
OPPI 2015 Final AW 1st Part For Printing.indd 12 02/10/2015 3:59:40 PM
• With a 72 per cent market share (in terms of revenue), generic drugs form the largest segment of the IPM
• Generic drugs account for 20 per cent of global exports in terms of volume, making India the largest provider of generic medicines globally.
Performance of the Indian Pharmaceutical Industry (Domestic) over last five years6
57868
Value in INR Crores
73514
78828
90085
66977
Market progression- 5 years
15%
9%
7%
14%
08
5 IBEF Pharmaceuticals report 2015 | 6 AIOCD-AWACS analysis
pharmaceutical(in per cent)5
OPPI 2015 Final AW 1st Part For Printing.indd 13 02/10/2015 3:59:40 PM
• Sales have increased continually year-on-year, demonstrating a typical pattern in movement. However, sales dipped in September 2013 for the first time, with negative sales growth.
• In FY 2014-15, industry revenue crossed the INR 7,000 crore mark for a single month in July 2014, the first month that this has ever happened. In the second half of that year, the market grew at 12.2 per cent, against 9.5 per cent the previous year, resulting in business improvement.
The key growth drivers in FY 2014-15 were new introductions in the non-NLEM category, price revisions and increased demand for existing products.
Snapshot of the Domestic Pharmaceutical Formulation market by Therapeutic Area, Multinational Companies (MNC) /Indian Split, Top Company Market Share and Brand Market Share over last four years7
7 AIOCD-AWACS analysis
Chronic-Acute Split
13%
10%
2012 2015
Acute
Chronic29 31
71 69
1.4x growth of chronic over acute therapy
2012 2015
Indian
MNC 24 22 8%
12%76 78
Indian-MNC Split
Domestic players account for more than 70% of the market and are growing aggressively
Share of top ten declined despite M&A
2012 2015
Top 10
11 to 30
30+ 13%
10%
12%
44.1 42.9
Top Company Market Share
32.7 33
23.1 24.1
Despite the challenging environment, top brands have exhibited leadership
2012 2015
Top 100
101 to 300
300+ 11%
13%
12%
16.6 17.5
Brand Market Share
14 14.3
69.4 68.2
09 ANNUAL REPORT 2014-15
In per cent
In per cent
In per cent
In per cent
OPPI 2015 Final AW 1st Part For Printing.indd 14 02/10/2015 3:59:41 PM
Formulations Export8
• Acute therapy gives momentum while Chronic Therapy drives IPM
• The market shares of multinational companies have declined due to greater exposure to the National List of Essential Medicines (NLEM 2011)
• While the market share of the top 10 companies by revenue has declined, top brands continued to register growth
Value in INR Crores
Volume in Thousands
9%
5%
500,000
400,000
300,000
200,000
100,000
0
Value Volume
8 AIOCD-AWACS analysis | 9CRISIL database 2014-15
India’s pharmaceutical exports were USD 14 bn in FY 2014-15 and are expected to grow at a healthy 12-14 per cent CAGR over the next five years. Indian pharmaceutical companies continue to capitalise on export opportunities in regulated and semi-regulated markets. The Ministry of Commerce and Industry estimates that pharmaceutical exports will reach USD 25 bn by 2020. Indian drugs are exported to more than 200 countries in the world, with the Americas accounting for around 34 per cent, followed by Europe (26 per cent) and Asia (20 per cent)
Bulk Drugs (Active Pharmaceutical Ingredients)A high growth trend in demand of the international generic drug industry continues to fuel the growth of bulk drugs. Domestic formulation growth will continue to have a direct impact on active pharmaceutical ingredient (API) sales in India. Bulk drug exports from India are expected to reach about USD 12.5 bn by the end of 2015.
In India, 85 per cent of bulk drugs produced are exported. India’s API export to regulated markets constituted roughly 48 per cent of its total API exports as of March 2015. Of this, 29 per cent of exports were to generic formulators (who produce drugs for which patents have expired) and 19 per cent to on-patent innovator formulators9.
10
OPPI 2015 Final AW 1st Part For Printing.indd 15 02/10/2015 3:59:41 PM
Position comparableto the US, achieved in just 10 years
Strong emergingpresence in areassuch as dermatology,topicals, etc.
Position primarily drivenby ARV’s significant potential to explore incremental innovation in other areas
Limited advancesmade so far, earlymovement seen forthe Indain market
52
22
10
5
11
India
US
Europe
Canada
Others
51
ANDA approvalsPer cent share, 2011-14
India 37
37
11
6
9
US
Europe
Israel
Others
ANDA approvalsPer cent share, 2011-14
US
Europe
India
Israel
Others
60
18
14
3
5
505(b)2 approvalsPer cent share, 2011-14
35
7
3
3
Europe
US
Japan
Canada
Others
NCE approvalsPer cent share, 2011-14
SpecialityGenerics
New therapeutic entities
New molecular entitiesGenerics
6 8
India is among the leaders for the Abbreviated New Drug Application (ANDA) approvals, but has a poor record when it comes to developing new therapeutic/molecular entities. The only success India has had so far is in development of anti- retrovirals.
Drug (Price Control) Order (DPCO) 2013 molecule basket vs Non-DPCOA recent study on ‘Assessing the Impact of price control measures on access to medicines in India’, released by IMS Health in 2015 shows a decline of 3 per cent in the volume share of DPCO molecules when compared to non-DPCO molecules. The report concludes that the primary beneficiaries of the DPCO 2013 price controls have been high income patient populations, rather than low-income target populations.
10 DoP presentation 2015 | 11 Indian Lifesciences 2030: Mckinsey-FICCI report
Research and Development (R&D) landscapeStatistics show that investments in R&D of the top 25 Indian companies have grown from INR 5060 crores (USD 1012 million ) in FY 2012-13 to INR 6103 crores ( USD 1110 million ) in FY 2013-14.
Yet India accounts for less than 1 per cent share of the US$ 142 bn in worldwide spending on pharmaceutical R&D during 2014. This is despite India’s unique strengths in this area: cost-competitive expertise in chemistry, availability of quality talent, a diverse patient pool and improving healthcare infrastructure. The Department of Pharmaceuticals (DoP) has envisaged developing India as a global drug discovery and pharmaceuticals innovation hub, capturing 15-20 per cent of the world’s R&D pipeline by 2020 leading to USD 70 bn in pharmaceuticals production10.
India currently has a nascent position in the innovation space, despite some initial small bets being placed11
ARV Combinations
11 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 1st Part For Printing.indd 16 02/10/2015 3:59:41 PM
Volume share
2007 2009 2011 2013 2015
22% 22% 25% 27% 30%
78% 78% 75% 73% 70%3 % decline in last 18 months
Non-DPCO DPCO
12
Clinical Trial Landscape
Clinical research is the only modality that will ensure newer lifesaving therapeutic options are made available for human use, particularly in domains of unmet medical needs. Without ethical clinical research, patient options are severely restricted.
The number of clinical trial applications received and permissions granted by the Central Drugs Standard Control Organization (CDSCO) during the last three years and in the current year are as below12:
Year No. of application received No. of permission granted*
2012 480 253
2013 207 73
2014 230 198
2015 87 137 (till 30/06/2015)
* Includes permissions granted for applications received during previous years.
A lot of uncertainty prevails around the future of clinical research in the country. Ironically, India accounts for around 17 per cent of the world’s population and 20 per cent of the global disease burden, with no clear clinical research agenda of our own to tackle this mammoth disease burden.
12 Q No. 2065: Raised in Lok Sabha in monsoon session
The graph depicts the volume share of DPCO Vs Non-DPCO molecules over 2007 - 2015
OPPI 2015 Final AW 1st Part For Printing.indd 17 02/10/2015 3:59:41 PM
Actions that impact the pharmaceutical sector
• The Department of Pharmaceuticals (DoP) announced plans to re-launch the Jan Aushadhi scheme of
generic pharmacies from July 2015, expand selection of products included in the scheme to over 500,
and involve private retail pharmacies, in addition to specialised Jan Aushadhi stores.
• Prescribing in the public sector will be shaped largely by the National List of Essential Medicines (NLEM).
A Core Committee instituted by the Government has been tasked with the revision of the NLEM 2011.
A series of consultative meetings across the country have concluded and the list is awaited.
• Enforcement of the DPCO 2013 has increased the proportion of the market subject to price control.
Certain amendments to the DPCO 2013 are underway and pharmaceutical associations have submitted
their suggestions.
• A voluntary ‘Uniform Code of Pharmaceuticals Marketing Practices’ (UCPMP) was formalised from
January 01, 2015. Adoption and compliance was to be reviewed after six months. The revised time-line
for the review has been extended to August 31, 2015.
• An Integrated Pharmaceutical Database Management System (IPDMS) has been set up to facilitate the
online submission of information required under the DPCO 2013 by companies.
Recent pronouncements by officials appear to indicate a growing awareness of the importance of the
healthcare sector – and by extension the pharmaceutical industry – that goes beyond costs to the need
for leveraging India’s advantages in building an innovation culture. Associated with this awareness is also
recognition that having a robust Intellectual Property Rights (IPR) regime is important for the economy as a
whole. The government is currently reviewing a draft National IPR policy; in the coming year, public discourse
on the key issues of innovation, improving the IPR regime and the attendant benefits on access to healthcare
is likely to grow louder.
For more than 25 years, Gilead has worked to develop medicines that address areas of unmet medical need for people around the world.
Our portfolio of medicines and pipeline of investigational drugs include treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions.
Every day we strive to transform and simplify care for people with life-threatening illnesses.
Advancing Therapeutics,ImprovingLives.
For more information, please visit www.gilead.com.© 2015 Gilead Sciences, Inc.
13 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 1st Part For Printing.indd 18 02/10/2015 3:59:41 PM
For more than 25 years, Gilead has worked to develop medicines that address areas of unmet medical need for people around the world.
Our portfolio of medicines and pipeline of investigational drugs include treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases and cardiovascular conditions.
Every day we strive to transform and simplify care for people with life-threatening illnesses.
Advancing Therapeutics,ImprovingLives.
For more information, please visit www.gilead.com.© 2015 Gilead Sciences, Inc.
OPPI 2015 Final AW 1st Part For Printing.indd 19 02/10/2015 3:59:41 PM
Working Groups (WG)Access and Affordability
Objectives:
l To support improvement in healthcare access and proactively engage in policy development
l Undertake research and studies to evaluate the impact of healthcare access and participate in the discourse on shaping policy
l To define OPPI’s position on enhancing access to healthcare and improving healthcare financing
l To bring together diverse stakeholders for a comprehensive dialogue on healthcare access issues
OPPI instituted a study with IMS Health on ‘Assessing the impact of price control measures on access to medicines in India’ in order to understand the effectiveness of price controls as a means to improve access. The study reviewed the DPCO 2013 and compared it with the DPCO 1995, to consider the relative impact of price controls on the entire healthcare ecosystem, predominantly on the true intended beneficiaries - the patients. The study identified certain critical levers which could help improve access to medicines in the country. The study concluded that India needs an all-encompassing healthcare model that will help achieve the objective of improving healthcare access in India, with the government in a lead role, supported by other stakeholders.
The WG worked on a paper on Healthcare Financing that analysed the merits of various financing and insurance approaches in addressing healthcare needs in emerging economies, while considering the learnings from developed economies. The paper outlined a role for regulatory and financing policy in expanding healthcare coverage and access.
The Fourth Healthcare Access Summit was held on August 7, 2015 in Mumbai. IMS was the principal partner at the summit. The event was supported by ASSOCHAM, AMCHAM, CII and FICCI. Leaders from the pharmaceutical industry, government officials, healthcare policy experts, medical practitioners and other distinguished professionals participated in an engaging discussion and presented solutions to make healthcare accessible.
The OPPI Healthcare Access Award 2015, supported by Abbott Healthcare and Johnson & Johnson, recognises the highest contribution made by an individual or institution toward improving access to healthcare with consideration for patient safety and adherence to quality. The jury to select the awardee comprised of Dr Srinath Reddy, Public Health Foundation of India; Dr Rajendra Gupta, Consultant; Gautam Kumra, McKinsey & Co; Dr Rajesh Upadhyay, APICON and Dr Shailesh Ayyangar, President, OPPI. Padma Bhushan Dr Devi Shetty, Chairman & Founder, Narayana Health, was declared the winner. Dr Shetty leads the way in providing affordable and world-class treatment for heart ailments.
OPPI has commissioned a study with KPMG on the Corporate Social Responsibility initiatives of its member companies that contribute to improved health outcomes in India.
CHAIRMAN: Sudarshan Jain (Abbott)
CO-CHAIRMAN: Sanjiv Navangul (Johnson & Johnson)
MEMBERS: Shirish Ghoge (Abbott ) • Pushpak Khare (Abbott) • Sanjeev Panchal (AstraZeneca) • Navin Sharma
(Baxter*) • Pooja Vatsyayan (Biogen Idec*) • Meenal Gauri (Boehringer Ingelheim) • Anil Kumar (Bristol-Myers
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Squibb) • Edgard A. Olaizola (Eli Lilly) • Munish Malhotra* / Anant Garg (Eli Lilly) • S Raghavendra* (Galderma)
• Dr Rahul Bargaje (Gilead Science) • Sudheendra Kulkarni (Johnson & Johnson) • Priya Hingorani (Johnson &
Johnson) • Shilpa Arora (Merck Serono) • Ashis Mukherjee* / Vivek Kamath (MSD Pharmaceuticals) • Sanchit
Nanda (Novartis) • Vinay Ransiwal (Novo Nordisk) • Partha Ghosh (Pfizer) • Umang Chaturvedi (Ranbaxy*)
• V Simpson (Roche) • Sangita Topiwala (Sanofi) • M.K. Narayanaswamy (Sanofi) • Geeta Karnik (Serdia) • Mahesh
Kalsekar (Takeda) • K. Venkatesh (UCB) • Deep Bhandari (UCB) • Sudip Chakraborty (UCB)
SPECIAL INVITEES: Shrikant Ganduri (Yes Bank) • Amit Backliwal* / Nitin Goel / Amit Mookim / Kunal Khanna
(IMS Health)
*Resigned
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Communications and Public Affairs
Objectives:
l To provide communications support to all WGs and Committees
l Prepare a communication tool kit for members
l Prepare OPPI position papers on identified industry issues
l To ensure consistent media engagement and balanced coverage in the press
l Increase the share of OPPI voice in media – to be consistently monitored
l Increase presence in social media
The WG identified and prioritised three focus areas for consistent communication: Innovation, Access to Healthcare and Ethics & Compliance. Based on these thrust areas, a tool kit with key messages was created for consistent and uniform messaging.
Ad Factors PR was appointed as OPPI’s new PR Agency to help enhance the image of OPPI and increase its visibility.
The WG was mandated to deliver on two specific initiatives; OPPI’s 50th year celebrations, and a Corporate Film. Special Task Forces (TFs) were formed to ensure smooth completion of these tasks.
The TF responsible for the corporate film was involved in the selection of the film-maker, the final storyboard and the entire making of the film. The film traces the 50 year journey of OPPI in India and, importantly, its role in transforming the healthcare landscape of the country. The film also showcases the work of the member companies in the field of innovation and drug research.
‘Healthy India. Innovative India.’ was selected as the theme for the 50th year celebrations. Another TF is supporting a year-long series of events around these celebrations, playing an active part in the specially constituted, high-level Steering Committee that is focused on this specific purpose.
Efforts were made by the WG to use the OPPI Blog, Twitter and Facebook to consistently engage with the public.
CHAIRMAN: Ranjit Shahani (Novartis)
CO-CHAIRPERSON: Ranjana Smetacek (OPPI)
MEMBERS: Varsha Chainani (Abbott) • Sridhar Ranganathan (Allergan) • Rajesh Mehra* / Varsha Das (AstraZeneca)
• Aloke Pradhan (Bayer) • Sophia Gonsalves (Bayer) • Neeti Khullar (Boehringer Ingelheim) • Kanchana
T.K. (Bristol-Myers Squibb) • Dr. Gaurav Arya* / Munish Malhotra* / Anant Garg (Eli Lilly) • Nandini Goswami* / Ransom
D’Souza (GSK Pharmaceuticals) • Ransom D’Souza* (Johnson & Johnson) • Rimmi Harindran (Merck Serono)
• Jyotsna Ghoshal (MSD Pharmaceuticals) • Neelima Dwivedi (MSD Pharmaceuticals) • Svetlana Pinto (Novartis)
• Sundeep Kumar (Novartis) • Anupama Rau (Novo Nordisk) • Sharad Goswami (Pfizer) • Umang Chaturvedi
(Ranbaxy*) • Shilpika Das (Roche) • Ranjita Sood (Roche) • Aparna Thomas (Sanofi) • Ruchita Mehra (Sanofi)
• James Fernandes (Serdia) • Ashish Ranjan (UCB)
*Resigned
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Ethics & Compliance
Objectives:
l To build visibility and awareness for the OPPI Code of Conduct
l To work with Government to formalise the Uniform Code of Pharmaceuticals Marketing Practices (UCPMP)
For responsible healthcare to become the norm in India, and patients to be guaranteed safe care and quality medicines, the DoP formalised the UCPMP as a voluntary code, effective January 01, 2015. OPPI welcomed the efforts of the DoP in ensuring increased accountability with the highest ethical standards in manufacturing, marketing and prescribing.
The WG organised a series of interactions with healthcare professionals, patient organisations, hospital administrators and other stakeholders to discuss the UCPMP and the Medical Council of India (MCI) guidelines and understand their concerns, in order to make it effective and implementable.
OPPI has also had several rounds of consultations with the DoP and also met the Minister of Chemicals and Fertilizers and other government officials, in order to ensure that the entire industry is aligned with the marketing code. Where appropriate, the WG also sought clarifications on certain aspects of the UCPMP.
As requested by the DoP, the WG is currently working on the ‘best practices’ on complaint handling. For this, the WG invited the Advertising Standards Council of India (ASCI) to explain their methods of governance and regulation, reviewing them to explore if they could perhaps be adapted to the pharmaceutical industry.
The WG is also currently working on revising the OPPI Code of Conduct, based on the UCPMP and the updated IFPMA Code.
The WG organised the OPPI Ethics & Compliance Conclave with PwC and AZB as partners. There was active participation from the pharmaceutical industry, healthcare experts, patient organisations, government officials, regulatory authorities, pharmaceutical associations and the Indian Medical Association (IMA). An array of eminent speakers participated in the various panel discussions through the day. The Conclave was instrumental in bringing forth constructive suggestions on making the UCPMP robust and practical.
CHAIRMAN: K. G. Ananthakrishnan (MSD Pharmaceuticals)
CO-CHAIRMAN: Maturin Tchoumi (Roche)
MEMBERS: Swati Dalal (Abbott) • Vijayaprakash Devulapalli (Abbott) • Rajesh Sharma (Allergan) • Ramesh
Varadarajan (AstraZeneca) • Rajiv Wani (Bayer) • Raelene Antao Banerjee (Bayer) • Neha Kshirsagar (Bayer) • Rajiv
Malhotra (Biogen Idec*) • Santosh Mane (Boehringer Ingelheim) • Bratin Bag* (Bristol-Myers Squibb) • P. Srikanth
(Eisai) • Dr Simrat Sohal (Eli Lilly) • Madhusudan HK (Galderma) • Susheel Sule (Gilead Sciences) • Mohit Raina
(GSK Pharmaceuticals) • Jayashree Shetty (Johnson & Johnson) • Dr Rajesh Chitre (Merck Serono) • Sandeep
Seth (MSD Pharmaceuticals) • Girish Tekchandani (Novartis) • Dr. Ramesh Jagannathan (Novo Nordisk) • Samir
Kazi (Pfizer) • Ashish Vohra (Pfizer) • Dr Jejoe Karan Kumar (Ranbaxy*) • Ravindra Jain (Roche) • Dan Chellman
(Roche) • Parichay Mittal* / Arjun Thakkar (Sanofi) • Bratin Bag (Sanofi) • Dr Asmita Nimkar (Serdia) • Ashok
Bhattacharya (Takeda) • Dolcy Dsouza (Takeda) • Milind Kulkarni (UCB)
*Resigned
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Innovation and Intellectual Property Rights IPR
Objectives:
l To help create a positive environment for (IPR) and encourage research and innovation
l To bring about a balance in discussions around Innovation and IPR
l To persuade key stakeholders that Innovation and IPR are good for the country
The WG developed a coordinated approach with stakeholders, aligning with PhRMA, IFPMA, EFPIA to build stronger advocacy. The group created position papers on critical topics: the Compulsory Licensing (CL) provision in the Indian Patent Act 1970, government control on patented medicines in India and on patentability. The shorter versions of these papers are available on the OPPI website.
The WG shared these OPPI positions with several government agencies and stakeholders. The group also prepared case studies and other reference materials for members to use when presenting the case for strong IPR in academic institutions or at public debates.
In December 2014, the IPR think tank set up by the Ministry of Commerce and Industry submitted the first draft of a National IPR policy, and called for comments on it. OPPI submitted recommendations to the think tank on the draft IPR Policy, followed by an interaction with them. Presently, the draft Policy is being circulated for inter-ministerial discussions. Finally, it will be reviewed by the Commerce Minister and then sent to the Cabinet for approval and announcement. Such a policy can provide a visionary national framework and act as a blue-print on how to utilise an IPR system, promote socio-economic and technological progress and development, and achieve international co-operation, trust and exchange.
CHAIRMAN: Aijaz Tobaccowalla (Pfizer)
CO-CHAIRPERSONS: Angel-Michael Evangelista (Bayer) • Jitendra Tyagi (Bristol-Myers Squibb) • K Shivkumar*
(Eisai)
MEMBERS: Shyamakant Giri (Abbott) • Pankaj Jain (AstraZeneca) • Dr. Ashish Gawde (Bayer) • Kedar
Suvarnapathaki (Boehringer Ingelheim) • Kanchana T.K. (Bristol-Myers Squibb) •Suresh Gupta (Bristol-Myers
Squibb) • Edgard A. Olaizola (Eli Lilly) • Kaizad Hazari (GSK Pharmaceuticals) • Ashish Srivastav (Johnson &
Johnson) • Nishant Berlia (Martin & Harris) • Prashant Laghate (Merck Serono) • Milind Thatte (Merck Serono)
• Vivek Kamath* / Anjan Sen (MSD Pharmaceuticals) • Swashraya Shah (MSD Pharmaceuticals) • Dinesh Charak
(Novartis) • Dr Ramesh Krishnamurti (Novo Nordisk) • Dr Srishyla (Novo Nordisk) • V Kumar (Pfizer) • Sharad
Goswami (Pfizer) • Shivprasad Laud (Roche) • Sujatha Subramaniam* / Rahul Vartak (Roche) • Yasmin Cama
(Sanofi) • Dr Mubarak Naqvi (Sanofi) • James Fernandes (Serdia) • Dr Sangeeta Madhok (UCB)
*Resigned
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Medical and Regulatory
Objectives:
l To provide inputs for changes in policies affecting new drug approvals, biologics and vaccines, and other regulatory issues (like import registration).
A number of sub-groups were formed.
The Import Registration sub-group took up the specific issue of import registration of manufacturers’ sites. Presently, the CDSCO calls for registration of multiple sites involved in the manufacture of a single product. OPPI is in dialogue with regulators; the sub-group recommended removal of the three-month window for cancellation of the registration certificate in case there are changes in the constitution of the firm, or the address.
The New Drug Approval sub-group addressed the issue of clinical trial waiver for new drugs. The sub-group made a representation to the Minstry of Health and Family Welfare (MoHFW) and Drugs Controller General (India) seeking a waiver for local clinical trial data for medicines that treat life-threatening diseases. An indicative list was submitted along with a definition of what should be considered a ‘life-threatening condition’.
The Biologics and Vaccines sub-group focused on registration and import licenses, and is in dialogue with regulatory bodies to simplify the registration approval process for imported products.
The Clinical Trials sub-group led the discussion on issues related to AV recording and the restriction on number of studies per investigator. It has had meaningful meetings with the Directorate General of Health Services and the MoHFW on those issues. The sub-group also submitted a proposal for training and skill development for CDSCO inspectors, and another on Good Clinical Practices and Drug Development with Indian Society for Clinical Research. This group submitted inputs on the changes proposed in the Drugs and Cosmetics Amendment Act and Rules.
CHAIRMAN: Sameer Savkur (Biogen Idec*)
CO-CHAIRPERSONS: Anish Bafna (Baxter*) • Dr Suresh Menon (Novartis) • Suneela Thatte (Quintiles)
MEMBERS: Dr Balagopal Nair (Abbott ) • Arun Mishra* (Abbott) • Dr Paramjit Singh (Allergan) • Dr Thirumalai
Velu (Allergan) • Dr Veena Jaguste (Amgen) • Dr Shashwati Pramanik (Amgen) • Dr Pratik Shah (Astellas)
• Dr Bhavesh Kotak (AstraZeneca) • Dr Ashish Gawde (Bayer) • Girish Parhate (Bayer) • Meenu Batolar (Biogen
Idec*) • Dr Viraj Suvarna (Boehringer Ingelheim) • Dr Vinod Mattoo (Bristol-Myers Squibb) • Dr Ramakrishnan
Sundaram (Bristol-Myers Squibb) • Anilda D’souza (Bristol-Myers Squibb) • Dr Chandrashekhar Chavan (Eisai)
• Dr Anurita Majumdar* (Eli Lilly) • Rahul Chauhan (Eli Lilly) • Dr Sachin Rustagi (Galderma) • Dr Vrishali Desai
(GSK Pharmaceuticals) • Sukanya Choudhury (GSK Pharmaceuticals) • Dr Prashant Desai (Johnson & Johnson)
• Dr Vikram Singh (Johnson & Johnson) • Nishant Berlia (Martin & Harris) • Dr Qayum Mukaddam (Merck Serono)
• Dr Priya Chatterjee (Merck Serono) • Swarnaraj Jacob* / Rahul Luthra (MSD Pharmaceuticals) • Swashraya Shah
(MSD Pharmaceuticals) • Amita Bhave (Novartis) • Dr Ramesh Jagannathan (Novo Nordisk) • Dr Chandrashekhar
Potkar* / Sharad Goswami (Pfizer) • Dr Sonali Dighe* (Pfizer) • Dr Manish Paliwal* (Pfizer) • Sofi Joseph (Pfizer)
• Dr Anurita Majumdar (Pfizer) • Rajgopal Bhutada (Ranbaxy*) • Dr Anil Kukreja (Roche) • Seema Shimpi (Roche)
• Dr Mubarak Naqvi (Sanofi) • Yasmin Shenoy (Sanofi) • Dr Asmita Nimkar (Serdia) • Dr Santosh Jha (Takeda)
• Dr Sangeeta Madhok (UCB)
SPECIAL INVITEE: Shrikant Ganduri (Yes Bank)
*Resigned
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Committees
Finance and Taxation
Objectives:
l To provide inputs for OPPI representations on Patented Product Pricing Policy and other pharmaceutical policy issues
l To work closely with IPA and IDMA to develop representations on the proposed amendments to the DPCO 2013 and revision of NLEM 2011
l To provide industry inputs for the Union Budget 2015-16
l To study the implementation challenges of the Goods and Services Tax (GST)
l To oversee OPPI Accounts and Administration
The inter-ministerial Committee on Patented Product Pricing Policy invited OPPI and other pharmaceutical associations to discuss the methodology in formulating a policy for the country. A cross-functional TF, with members from the IPR and Innovation WG along with a few members of the Finance and Taxation Committee, worked closely with PhRMA to develop a position paper on the subject.
A Core Committee formed by Government for revision of the NLEM 2011 held six consultative meetings across the country. These meetings were attended by experts from the OPPI member companies, who put forward industry concerns to be addressed while revising the NLEM 2011. OPPI also submitted suggestions to the chairman of the Core Committee.
OPPI highlighted operational issues affecting the effective implementation of the DPCO 2013 and provided inputs on proposed amendments. OPPI, in collaboration with IDMA and IPA, is working with Government to ensure access to medicines to patients in India.
With help from associate members, E&Y and KPMG, the Committee submitted OPPI’s Pre-Union Budget Memorandum to relevant ministries and departments. The memorandum was prepared in consultation with other associations such as IDMA, IPA, FICCI, CII & ASSOCHAM. The TF made several presentations to DoP/DoR on direct taxes, indirect taxes and transfer pricing elements affecting the pharmaceutical industry. Subsequently, post-budget recommendations, with inputs from industry bodies, were also submitted to Government.
The Committee made suggestions on augmenting OPPI’s Accounts and Administration and ensured statutory compliance of financial matters, as directed by Deloitte Haskins and Sells.
The Committee conducted a series of knowledge sessions: ‘Strategic Levers for Successful Drug Commercialisation in India’ by Varun Gupta, Novartis; ‘Union Budget 2015-16 Analysis - Inspiring Confidence and Empowering Change in India’ by Hitesh Gajaria, KPMG; ‘GST: impact, insight and way forward’ by Hitesh Sharma, E&Y, and a session on ‘Computation and Disclosure Standards (ICDS) for Computation of Taxable Income’ by Dinesh Jangid, KPMG.
CHAIRMAN: Aman Bajaaj (Takeda)
CO-CHAIRMAN: Melvin D’Souza (Novo Nordisk)
MEMBERS: Sachin Dharap (Abbott) • Shirish Ghoge (Abbott) • Rajesh Sharma (Allergan) • Dr Pratik Shah
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(Astellas) • Rajesh Marwaha (AstraZeneca) • Sandeep Devgon (Baxter*) • N.V. Chalapathi Rao (Bayer) • Davendra
Singhvi (Biogen Idec*) • Thomas Wilmesmeier (Boehringer Ingelheim) • Mukesh Agarwal* (Bristol-Myers Squibb)
• Kanchana T.K.* (Bristol-Myers Squibb) • Raghavendra Agarwal (Bristol-Myers Squibb) • Vikram Arora (Eli Lilly)
• Kaushal Gupta (Fresenius Kabi) • Nimit Sanghvi (Galderma) • Sushil Khanna (GSK Pharmaceuticals) • Andrew
Aristidou (GSK Pharmaceuticals) • Manish Vora (Johnson & Johnson) • Kalpana Umakanth (Martin & Harris)
• Hemant Lad (Merck Serono) • Giri Giridhar (MSD Pharmaceuticals) • Milind Patil (Novartis) • Suhas Karambelkar
(Novo Nordisk) • S. Sridhar (Pfizer) • Sharad Goswami (Pfizer) • Sundeep Mehta (Ranbaxy*) • Patrick Watkins
(Roche) • M.K. Narayanaswamy (Sanofi) • Vaibhav Karandikar (Sanofi) • Geeta Karnik (Serdia) • Vinay Potdar
(Takeda) • Satish Joshi (UCB)
SPECIAL INVITEES: Hitesh Sharma (Ernst & Young) • Hitesh Gajaria (KPMG) • Shrikant Ganduri (Yes Bank)
*Resigned
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Governance and Human Resources Management
Objectives:
l To conduct an industry benchmarking study for member companies - OPPI Field Force Compensation Study 2015
l To leverage relationships with other industry associations to jointly address industrial relations (IR) issues in the pharmaceutical industry
l To work closely with the Life Sciences Skill Development Council (LSSDC) and academia to make the pharmaceutical industry an employer of choice
l To organise knowledge sessions and the OPPI HR Summit 2015
OPPI has been engaging with the students and faculty of top management institutes through the OPPI Academia Programme. This is designed to initiate dialogue between the industry, the future workforce and academia. As part of this initiative, the Committee visited some management and research institutes across the country, including the National Institute of Pharmaceutical Education and Research (NIPERs). The objective was to gauge levels of interest among students towards the pharmaceutical industry and promote it as an industry of choice for young employees.
The Committee partnered with Aon Hewitt to conduct a study among member companies on compensation and benefits across various categories of Medical Representatives (MRs), and the sales and marketing functions. The study, which captures several aspects of compensation and benefits, will help member companies streamline remuneration in this area.
The Sales Promotion Employees (Conditions of Service) Act, 1976, was enacted by Parliament to regulate the services of sales promotion employees. However, given the different and specialised nature of their work, the Act has not prescribed work timings for MRs. OPPI, along with IDMA, has made several representations in various states against enforcing working hours for MRs.
OPPI’s HR Summit on ‘HR Imperatives & Organisational Sustainability’ was held on September 15, 2015 in Mumbai. Discussions at the summit covered diversity and inclusion, compliance and governance, and the Employee Value Proposition (EVP).
OPPI, along with other industry associations, supports the Life Sciences Sector Skill Development Council, which is focused on skill development in the pharmaceutical industry. OPPI has provided inputs on curriculum design, and in addition supported specific areas such as infrastructure and creation of a pool of Master Trainers and Assessors.
The Committee organised knowledge sessions: V. Srinivas, Illumine Knowledge Resources Pvt Ltd, conducted a programme on ‘Building Contributors in Organisations’. Ashish Ambasta, Towers Watson India, conducted a session on ‘2015 Asia-Pacific Market Trends/Insights for the Pharmaceuticals & Life Sciences Sector’ in which he shared recent trends in rewards in the pharmaceutical industry.
CHAIRMAN: K. Shivkumar* (Eisai) • Sharad Tyagi (Boehringer-Ingelheim)
MEMBERS: Ajay Bhatt * / Deepshikha Mukerji (Abbott) • Debashish Chatterjee (Allergan) • Kinnari Joshi (Astellas)
• Smita Saha (AstraZeneca) • K.S. Harish (Bayer) • Vikram Patki* (Bayer) • Garvita Bhandari (Biogen Idec*)
• Sanjay Srivastava (Boehringer-Ingelheim) • Shraddha Pradhan* / Deepa Shankar (Bristol-Myers Squibb) • Bhakti
Gokhale* / Preston Fernandes (Eisai) • Ranjit Singh Walia (Eli Lilly) • Tarkesh Gupta (Fresenius Kabi) • Abhigyan
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Ghosh (Galderma) • Dr Rahul Bargaje (Gilead Sciences) • Ronald Sequeira (GSK Pharmaceuticals) • Anupam
Shrihari (Johnson & Johnson) • Cecilia M. Azavedo* / Milind Thatte (Merck Serono) • Vikram Patki (Merck Serono)
• Sameer Tamhane (MSD Pharmaceuticals) • Meenakshi Priyam (Novartis) • Malapaka SRKV Murthy* / Amit
Kumar Das (Novo Nordisk) • Dr Lakshmi Nadkarni* (Pfizer) • Ravi Subramanian (Pfizer) • Vikram Duggal (Ranbaxy*)
• Nilesh Kulkarni (Roche) • Gaurav Bahadur (Sanofi) • Rohit Kumar (Sanofi) • Jui Dabir (Serdia) • Deepa Misra
(Takeda) • Ashish Ranjan (UCB)
*Resigned
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Legal
Objectives:
l To monitor and review changes in laws and policies affecting the pharmaceutical industry
l To act as an advisory and consultant on legal issues
l Review all IPR related cases impacting member companies
l Keep member fully aware of the changes relating to Company law, Patent law, Pricing and Competition law
l Identify key business issues facing member companies from a legal perspective and develop a common understanding and approach
l Defend the legal rights of the member companies to do business in India under Indian laws
l Support all WGs and Committees as and when needed.
NPPA’s use of Para 19 in the DPCO 2013 extended price control to several non-scheduled medicines. OPPI has challenged the constitutional validity of NPPA’s action in the Delhi High Court. Final arguments are being heard in this case.
NPPA has proposed amendments to the DPCO 2013. A cross-functional TF, with members from the Legal and Finance and Taxation Committees, prepared the OPPI position on this. The Committee also submitted a representation on the NPPA’s notification on change of definition of ‘non-schedule’ drug under Para 2 (v) of the DPCO 2013.
The Committee studied the legal interpretations of the UCPMP guidelines and provided inputs to the Ethics and Compliance WG.
A position paper on online sales of over-the counter (OTC) and prescription drugs by e-pharmacies is under preparation.
The Committee has been providing relevant data to government authorities and continues to provide regular inputs to the Medical and Regulatory WG and Finance and Taxation Committee for action items on relevant cases.
CHAIRMAN: G. Sathya Narayanan (Galderma)
CO-CHAIRMAN: Sanjay Murdeshwar (AstraZeneca)
MEMBERS: Kaiyomarz Marfatia (Abbott) • Anurag Sharma (Abbott) • Pankaj Jain (AstraZeneca) • Anuranjan Prasad
(Baxter*) • Rajiv Wani (Bayer) • Neha Kshirsagar (Bayer) • Santosh Mane (Boehringer-ingelheim) • Edgard A. Olaizola
(Eli Lilly) • Nilesh Pingle (Fresenius Kabi) • Kaizad Hazari (GSK Pharmaceuticals) • Sanjeev Shrivastav* / Tapan Pati
(Johnson & Johnson) • Vikas Gupta (Merck Serono) • Muralidhar Karnam (MSD Pharmaceuticals) • Dinesh Charak
(Novartis) • Kavery Madappa (Novo Nordisk) • Samir Kazi (Pfizer) • Akhilesh Nand (Ranbaxy*) • Shivprasad Laud
(Roche) • Yasmin Cama (Sanofi) • Partha Sil (Sanofi) • Geeta Karnik (Serdia) • Satish Joshi (UCB)
*Resigned
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31 ANNUAL REPORT 2014-15 26
Technical and Supply Chain
Objectives:
lTo share knowledge on good practices and ensure compliance
lTo collaborate with DoP and National Institute of Pharmaceutical Education and Research (NIPERs)
lTo facilitate the creation of ‘Pharmazones’
lTo prepare a research paper on ‘Temperature controlled (cold chain) supply chain in India’
In February 2015, OPPI partnered with the Federation of Asian Biotech Association (FABA) in BioAsia 2015 held in Hyderabad. With participation from over 20 Asian countries, BioAisa 2015 created a global platform for discussions on the ‘New Era of Life Sciences - Opportunities in transition’. OPPI co-organised a seminar on Supply Chain and Logistics; participation from across the industry was a highlight of the seminar.
During the course of the year, the Committee organised knowledge sessions on ‘Electronic Stock and Sales System’ and ‘If Variable Barcodes are Made Mandatory’ by Ameesh Masurekar, AIOCD AWACS, and ‘Operational Efficiencies in the Supply Chain’ by Javin Bhinde, SynCore Consulting Group. As a member of the Academic Standards Committee of NIPER, OPPI provided regular inputs to NIPER on reducing current skill gaps in the industry. On request from the DoP, the Committee also provided inputs on the NIPER curriculm, suggestions on building industry and academia linkages and partnerships, and on strengthening Central Public Sector Enterprises.
A research paper on ‘Temperature Controlled (Cold Chain) Supply Chain’ prepared by OPPI examined the challenges in developing a temperature controlled supply chain and proposed recommendations for creating a best-practice compliant supply chain for pharmaceuticals in India. The Committee thanks DHL for providing significant inputs and allowing access to their data.
A TF led a site visit to Mezies Air Cargo Pvt Ltd’s terminal at Hyderabad Airport, and discussed issues on the infrastructure and logistics of pharmazones. A representation on these issues is being prepared, and will be submitted to Government soon.
Based on a TF-led visit to the Goa plants of Abbott, Merck Serono, Pfizer and Sanofi, representations were submitted on matters concerning FDA, DCGI, DCFT and implementation of Indian Pharmacopoeia 2014.
Annual Awards: The Committee managed the annual OPPI Scientist Awards and also supported the Best Vendor Award.
CHAIRMAN: Raghu Kumar (Allergan)
CO-CHAIRMAN: Dr Ramesh Panchagnula (Nektar)
MEMBERS: Shailendra Bobhate (Abbott) • Rajashekhar Akkaraju (Abbott) • K.T. Rajan (Allergan) • Devendra Mehta
(Astellas) • Robert Haxton* / Himanshu Saxena (AstraZeneca) • Vinay Phatak (Bayer) • Sanjay Manjrekar (Bayer)
• Raghavendra Agarwal* (Bristol-Myers Squibb) • Harsh Mehta (Bristol-Myers Squibb) • P. Thiyagarajan (Eli Lilly)
• Manas Sahoo (Fresenius Kabi) • Dr. Anand Dixit (Galderma) • Raju Krishnaswamy (GSK Pharmaceuticals) • Riju
Verma (Johnson & Johnson) • Aditya Berlia (Martin & Harris) • Rakesh Shah (Merck Serono) • Sanjay Bhatkhande
(MSD Pharmaceuticals) • Dharmesh Kharwar (MSD Pharmaceuticals) • Dr Firdosh Gardin (Novartis) • Suhas
Karambelkar (Novo Nordisk) • Vivek Dhariwal (Pfizer) • Sailesh Tekriwal (Ranbaxy*) • Arun Manjeshwar (Roche)
• Amit Nadkarni (Roche) • Krishna Parab (Sanofi) • Sadhana Mogre (Sanofi) • Santhosh Menon (Serdia) • Vinay
Potdar (Takeda) • Milind Kulkarni (UCB)
SPECIAL INVITEES: Ajit Singh (ACG) • Mohan Joshi (Consultant) • Ravind Mithe (KPMG) • Shrikant Ganduri (Yes Bank)
*Resigned
PROJECT JAWHAR:It takes between three and four hours to make the 128-km drive from Mumbai to Jawhar in Palghar district, a village in the tribal regions of rural Maharashtra. Once outside the city limits, it can be a lovely drive into the gentle slopes of the Western Ghats, with picturesque views of the countryside.
Three years ago, OPPI, in partnership with the government of Maharashtra, the Rotary Club, Mumbai, the Indian Medical Association and NGO Pragati Prathistan, launched Project Jawhar here, an initiative to lower the maternal mortality rate (MMR), a key global health indicator. Looking back at our work over these past years, there is reason to be proud.
The project’s goal is to promote awareness, reduce delays in emergency treatment, and encourage local women’s groups to understand and accept the importance of antenatal care, postnatal care, spacing children, and child immunisation. The project provides thousands of tribal women with access to healthcare and medicines that were severely lacking just a few years ago.
Project workers counsel the women about the risks of repeated pregnancies – stemming from the desire for a boy child; the physical and emotional trauma, and adverse effects on long-term health. Attention is paid to disseminating concepts of family planning and the importance of a nutritious diet during pregnancy and lactation.
Rekha, a young 24-year-old woman with a six-month-old baby girl, is grateful for the initiative. “Bringing the facilities to us and teaching us what to do has made our lives so much easier,” she tells a counselor. She brought her recently married and pregnant younger sister to one of the camps. “I tell all the women I know, about this camp.”
“I still remember the day we discussed this project with OPPI,” says Dr Bal Inamdar, former director general, Rotary Club, Mumbai. “They have been a strong pillar of support. OPPI member companies have provided medicines and also nutritional support to the women in the camps and have helped make a big difference.”
Over the last three years, thousands of women have participated in the antenatal and postnatal camps; they receive regular health checks and their newborns receive paediatric care as well. So today, there are close
Health checks organised in the camps
OPPI 2015 Final AW 2nd part For Printing 3 fold pages.indd 3 02/10/2015 4:03:32 PM
31 ANNUAL REPORT 2014-15 26
Technical and Supply Chain
Objectives:
lTo share knowledge on good practices and ensure compliance
lTo collaborate with DoP and National Institute of Pharmaceutical Education and Research (NIPERs)
lTo facilitate the creation of ‘Pharmazones’
lTo prepare a research paper on ‘Temperature controlled (cold chain) supply chain in India’
In February 2015, OPPI partnered with the Federation of Asian Biotech Association (FABA) in BioAsia 2015 held in Hyderabad. With participation from over 20 Asian countries, BioAisa 2015 created a global platform for discussions on the ‘New Era of Life Sciences - Opportunities in transition’. OPPI co-organised a seminar on Supply Chain and Logistics; participation from across the industry was a highlight of the seminar.
During the course of the year, the Committee organised knowledge sessions on ‘Electronic Stock and Sales System’ and ‘If Variable Barcodes are Made Mandatory’ by Ameesh Masurekar, AIOCD AWACS, and ‘Operational Efficiencies in the Supply Chain’ by Javin Bhinde, SynCore Consulting Group. As a member of the Academic Standards Committee of NIPER, OPPI provided regular inputs to NIPER on reducing current skill gaps in the industry. On request from the DoP, the Committee also provided inputs on the NIPER curriculm, suggestions on building industry and academia linkages and partnerships, and on strengthening Central Public Sector Enterprises.
A research paper on ‘Temperature Controlled (Cold Chain) Supply Chain’ prepared by OPPI examined the challenges in developing a temperature controlled supply chain and proposed recommendations for creating a best-practice compliant supply chain for pharmaceuticals in India. The Committee thanks DHL for providing significant inputs and allowing access to their data.
A TF led a site visit to Mezies Air Cargo Pvt Ltd’s terminal at Hyderabad Airport, and discussed issues on the infrastructure and logistics of pharmazones. A representation on these issues is being prepared, and will be submitted to Government soon.
Based on a TF-led visit to the Goa plants of Abbott, Merck Serono, Pfizer and Sanofi, representations were submitted on matters concerning FDA, DCGI, DCFT and implementation of Indian Pharmacopoeia 2014.
Annual Awards: The Committee managed the annual OPPI Scientist Awards and also supported the Best Vendor Award.
CHAIRMAN: Raghu Kumar (Allergan)
CO-CHAIRMAN: Dr Ramesh Panchagnula (Nektar)
MEMBERS: Shailendra Bobhate (Abbott) • Rajashekhar Akkaraju (Abbott) • K.T. Rajan (Allergan) • Devendra Mehta
(Astellas) • Robert Haxton* / Himanshu Saxena (AstraZeneca) • Vinay Phatak (Bayer) • Sanjay Manjrekar (Bayer)
• Raghavendra Agarwal* (Bristol-Myers Squibb) • Harsh Mehta (Bristol-Myers Squibb) • P. Thiyagarajan (Eli Lilly)
• Manas Sahoo (Fresenius Kabi) • Dr. Anand Dixit (Galderma) • Raju Krishnaswamy (GSK Pharmaceuticals) • Riju
Verma (Johnson & Johnson) • Aditya Berlia (Martin & Harris) • Rakesh Shah (Merck Serono) • Sanjay Bhatkhande
(MSD Pharmaceuticals) • Dharmesh Kharwar (MSD Pharmaceuticals) • Dr Firdosh Gardin (Novartis) • Suhas
Karambelkar (Novo Nordisk) • Vivek Dhariwal (Pfizer) • Sailesh Tekriwal (Ranbaxy*) • Arun Manjeshwar (Roche)
• Amit Nadkarni (Roche) • Krishna Parab (Sanofi) • Sadhana Mogre (Sanofi) • Santhosh Menon (Serdia) • Vinay
Potdar (Takeda) • Milind Kulkarni (UCB)
SPECIAL INVITEES: Ajit Singh (ACG) • Mohan Joshi (Consultant) • Ravind Mithe (KPMG) • Shrikant Ganduri (Yes Bank)
*Resigned
PROJECT JAWHAR:It takes between three and four hours to make the 128-km drive from Mumbai to Jawhar in Palghar district, a village in the tribal regions of rural Maharashtra. Once outside the city limits, it can be a lovely drive into the gentle slopes of the Western Ghats, with picturesque views of the countryside.
Three years ago, OPPI, in partnership with the government of Maharashtra, the Rotary Club, Mumbai, the Indian Medical Association and NGO Pragati Prathistan, launched Project Jawhar here, an initiative to lower the maternal mortality rate (MMR), a key global health indicator. Looking back at our work over these past years, there is reason to be proud.
The project’s goal is to promote awareness, reduce delays in emergency treatment, and encourage local women’s groups to understand and accept the importance of antenatal care, postnatal care, spacing children, and child immunisation. The project provides thousands of tribal women with access to healthcare and medicines that were severely lacking just a few years ago.
Project workers counsel the women about the risks of repeated pregnancies – stemming from the desire for a boy child; the physical and emotional trauma, and adverse effects on long-term health. Attention is paid to disseminating concepts of family planning and the importance of a nutritious diet during pregnancy and lactation.
Rekha, a young 24-year-old woman with a six-month-old baby girl, is grateful for the initiative. “Bringing the facilities to us and teaching us what to do has made our lives so much easier,” she tells a counselor. She brought her recently married and pregnant younger sister to one of the camps. “I tell all the women I know, about this camp.”
“I still remember the day we discussed this project with OPPI,” says Dr Bal Inamdar, former director general, Rotary Club, Mumbai. “They have been a strong pillar of support. OPPI member companies have provided medicines and also nutritional support to the women in the camps and have helped make a big difference.”
Over the last three years, thousands of women have participated in the antenatal and postnatal camps; they receive regular health checks and their newborns receive paediatric care as well. So today, there are close
Health checks organised in the camps
OPPI 2015 Final AW 2nd part For Printing 3 fold pages.indd 3 02/10/2015 4:03:32 PM
OPPI 2015 Final AW 2nd part For Printing 3 fold pages.indd 2 02/10/2015 4:03:30 PM
31 ANNUAL REPORT 2014-15 26
Technical and Supply Chain
Objectives:
lTo share knowledge on good practices and ensure compliance
lTo collaborate with DoP and National Institute of Pharmaceutical Education and Research (NIPERs)
lTo facilitate the creation of ‘Pharmazones’
lTo prepare a research paper on ‘Temperature controlled (cold chain) supply chain in India’
In February 2015, OPPI partnered with the Federation of Asian Biotech Association (FABA) in BioAsia 2015 held in Hyderabad. With participation from over 20 Asian countries, BioAisa 2015 created a global platform for discussions on the ‘New Era of Life Sciences - Opportunities in transition’. OPPI co-organised a seminar on Supply Chain and Logistics; participation from across the industry was a highlight of the seminar.
During the course of the year, the Committee organised knowledge sessions on ‘Electronic Stock and Sales System’ and ‘If Variable Barcodes are Made Mandatory’ by Ameesh Masurekar, AIOCD AWACS, and ‘Operational Efficiencies in the Supply Chain’ by Javin Bhinde, SynCore Consulting Group. As a member of the Academic Standards Committee of NIPER, OPPI provided regular inputs to NIPER on reducing current skill gaps in the industry. On request from the DoP, the Committee also provided inputs on the NIPER curriculm, suggestions on building industry and academia linkages and partnerships, and on strengthening Central Public Sector Enterprises.
A research paper on ‘Temperature Controlled (Cold Chain) Supply Chain’ prepared by OPPI examined the challenges in developing a temperature controlled supply chain and proposed recommendations for creating a best-practice compliant supply chain for pharmaceuticals in India. The Committee thanks DHL for providing significant inputs and allowing access to their data.
A TF led a site visit to Mezies Air Cargo Pvt Ltd’s terminal at Hyderabad Airport, and discussed issues on the infrastructure and logistics of pharmazones. A representation on these issues is being prepared, and will be submitted to Government soon.
Based on a TF-led visit to the Goa plants of Abbott, Merck Serono, Pfizer and Sanofi, representations were submitted on matters concerning FDA, DCGI, DCFT and implementation of Indian Pharmacopoeia 2014.
Annual Awards: The Committee managed the annual OPPI Scientist Awards and also supported the Best Vendor Award.
CHAIRMAN: Raghu Kumar (Allergan)
CO-CHAIRMAN: Dr Ramesh Panchagnula (Nektar)
MEMBERS: Shailendra Bobhate (Abbott) • Rajashekhar Akkaraju (Abbott) • K.T. Rajan (Allergan) • Devendra Mehta
(Astellas) • Robert Haxton* / Himanshu Saxena (AstraZeneca) • Vinay Phatak (Bayer) • Sanjay Manjrekar (Bayer)
• Raghavendra Agarwal* (Bristol-Myers Squibb) • Harsh Mehta (Bristol-Myers Squibb) • P. Thiyagarajan (Eli Lilly)
• Manas Sahoo (Fresenius Kabi) • Dr. Anand Dixit (Galderma) • Raju Krishnaswamy (GSK Pharmaceuticals) • Riju
Verma (Johnson & Johnson) • Aditya Berlia (Martin & Harris) • Rakesh Shah (Merck Serono) • Sanjay Bhatkhande
(MSD Pharmaceuticals) • Dharmesh Kharwar (MSD Pharmaceuticals) • Dr Firdosh Gardin (Novartis) • Suhas
Karambelkar (Novo Nordisk) • Vivek Dhariwal (Pfizer) • Sailesh Tekriwal (Ranbaxy*) • Arun Manjeshwar (Roche)
• Amit Nadkarni (Roche) • Krishna Parab (Sanofi) • Sadhana Mogre (Sanofi) • Santhosh Menon (Serdia) • Vinay
Potdar (Takeda) • Milind Kulkarni (UCB)
SPECIAL INVITEES: Ajit Singh (ACG) • Mohan Joshi (Consultant) • Ravind Mithe (KPMG) • Shrikant Ganduri (Yes Bank)
*Resigned
PROJECT JAWHAR:It takes between three and four hours to make the 128-km drive from Mumbai to Jawhar in Palghar district, a village in the tribal regions of rural Maharashtra. Once outside the city limits, it can be a lovely drive into the gentle slopes of the Western Ghats, with picturesque views of the countryside.
Three years ago, OPPI, in partnership with the government of Maharashtra, the Rotary Club, Mumbai, the Indian Medical Association and NGO Pragati Prathistan, launched Project Jawhar here, an initiative to lower the maternal mortality rate (MMR), a key global health indicator. Looking back at our work over these past years, there is reason to be proud.
The project’s goal is to promote awareness, reduce delays in emergency treatment, and encourage local women’s groups to understand and accept the importance of antenatal care, postnatal care, spacing children, and child immunisation. The project provides thousands of tribal women with access to healthcare and medicines that were severely lacking just a few years ago.
Project workers counsel the women about the risks of repeated pregnancies – stemming from the desire for a boy child; the physical and emotional trauma, and adverse effects on long-term health. Attention is paid to disseminating concepts of family planning and the importance of a nutritious diet during pregnancy and lactation.
Rekha, a young 24-year-old woman with a six-month-old baby girl, is grateful for the initiative. “Bringing the facilities to us and teaching us what to do has made our lives so much easier,” she tells a counselor. She brought her recently married and pregnant younger sister to one of the camps. “I tell all the women I know, about this camp.”
“I still remember the day we discussed this project with OPPI,” says Dr Bal Inamdar, former director general, Rotary Club, Mumbai. “They have been a strong pillar of support. OPPI member companies have provided medicines and also nutritional support to the women in the camps and have helped make a big difference.”
Over the last three years, thousands of women have participated in the antenatal and postnatal camps; they receive regular health checks and their newborns receive paediatric care as well. So today, there are close
Health checks organised in the camps
OPPI 2015 Final AW 2nd part For Printing 3 fold pages.indd 3 02/10/2015 4:03:32 PM
32
to 7000 happy mothers – and probably an equal number of happy children – in Jawhar, Mokhada and Vikramgad, who came from as far as 40 kms away to the 53 health camps that were conducted as part of Project Jawhar.
Dr Bharat Mahale, a gynaecologist, at Cottage Hospital, Jawhar, has been associated with this project from its inception. “When we began, we faced two main challenges: low awareness of the risks of pregnancy among the women of Jawhar and nearby areas, and the shortage of medicines,” he recalls. “With every camp, we were able to slowly gain the trust and build confidence among the womenfolk. This has been largely due to the consistent supply of branded medicines from OPPI members companies and a strong word of mouth.”
There are many who express their gratitude to Government and to the counselors and workers of Project Jawhar as much as Rekha does, saying it is has made a real difference in their lives.
At Jawhar, we have helped build health literacy levels among sections of women who otherwise would not have access to information, besides providing the support and care they need during this phase in their lives.
“We believe that the outcomes achieved here go far beyond just improving maternal health,” says Lata one of Project Jawhar’s healthcare workers. “I think it has made a big difference to the quality of the families’ lives.”
Doctors report marked declines in the number of cases of severe anaemia, and equally notable improvements in Hb levels of several women. “Among all the women who attended the camps, not even one instance of maternal mortality has been reported,” says Dr Jayesh Lele, President Elect, IMA, Maharshtra State, who works at the camps. “That is a result we can be truly proud of.”
The outcomes are reflected in healthcare indicators too. In the UN’s Millennium Development Goals (MDGs), for example: the MMR target for India was 140 per hundred thousand births, to be achieved by 2015 (in 2012, it was 178). Government officials say that at the current compounded rate of decline, achieving the MDG target by the end of the year is possible.
The past three years have been very rewarding for all who participated in this initiative. There have been several learnings from Project Jawhar that have enhanced our knowledge and enriched our experience. In many parts of rural India, women are still denied basic access to healthcare. Perhaps the lessons from Jawhar can be leveraged in other, similar projects in the coming years.
A happy mother Women engrossed in a lecture in the camp
OPPI 2015 Final AW 3rd Part For Printing.indd 3 02/10/2015 4:06:13 PM
31 ANNUAL REPORT 2013-14 32
OPPI 2015 Final AW 3rd Part For Printing.indd 6 02/10/2015 4:06:20 PM
Meeting with Policy Makers and Government Authoritiesw.e.f August 16, 2014
Date Ministers / Officials Delegation Purpose
• Dr V.M. Katoch Director General, ICMR & Secretary, Department of Health Research
• Dr Y.K. Gupta Prof & Head, Department of Pharmacology, AIIMS
• Shri Rajeev Kher Secretary Commerce
• Shri Amitabh Kant Secretary, DIPP
• Ms Sujata Mehta Secretary, ER (MEA) Ministry of External Affairs
• Ms Aradhana Johri Secretary, DoP
• Shri K.L. Sharma Joint Secretary, Department of Health, MoH&FW
• Shri D.V. Prasad Joint Secretary, DIPP
• Shri Rajeev Arora Joint Secretary, (Com)
• Ms Chandni Raina Director, DIPP
• Ms Mugdha Sinha Director, Department of Commerce
• Ms Aradhana Johri Secretary, DoP
• Sameer Savkur, Biogen Idec and Vice President, OPPI
• Shirish Ghoge, Abbott
• Dr Gaurav Arya, Eli Lilly
• Dr Ratnesh Lal, MSD
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Sameer Savkur, Biogen Idec and Vice President, OPPI
• Shirish Ghoge, Abbott
• Dr Gaurav Arya, Eli Lilly
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Ranjit Shahani, Novartis and Immediate Past President, OPPI
• Sameer Savkur, Biogen Idec and Vice President, OPPI
• K G Ananthakrishnan, MSD and Vice President, OPPI
• Aijaz Tobaccowalla, Pfizer and Vice President, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Ranjit Shahani, Novartis and Immediate Past President, OPPI
Discussion on Innovation and IPR
Discussion on Innovation and IPR
Discussion on challenges in the pharmaceutical industry
Discussions on the various issues related to the pharmaceutical industry
1 28.08.2014
2 09.09.2014
3 15.09.2014
4 15.09.2014
36
OPPI 2015 Final AW 3rd Part For Printing.indd 7 02/10/2015 4:06:20 PM
• Ms Aradhana Johri Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Officials from NPPA
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Shri Amit Khare Member Secretary, NPPA
• Dr M. Ariz Ahammed Joint Secretary, DoP
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Shri Sudhansh Pant Joint Secretary, DoP
Matters related to the DPCO 2013/ Pharmaceutical Policy issues
Industry related issues
Discussions on Guidelines dated August 20, 2014 issued by Odisha State Drug Control Department, for sale of drugs in Odisha
Courtesy call
Courtesy call
Matters related to New Drug Approval Process, Clinical Trials, Biosimilars and Import Regulation
Courtesy call
• Sameer Savkur, Biogen and Vice President, OPPI
• K.G. Ananthakrishnan, MSD and Vice President, OPPI
• Aijaz Tobaccowalla, Pfizer and Vice President, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Ranjana Smetacek, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Aijaz Tobaccowalla, Pfizer and Vice President, OPPI
• Shirish Ghoge, Abbott
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Amitabh Baxi, Abbott
• Khomba Singh, Pfizer
• Prem Singh Rawat, OPPI
• Tabrez Ahmad, OPPI
• Amitabh Baxi, Abbott
• Surbhi Chawla, BMS
• Dr Gaurav Arya, Eli Lilly
• Dr Ratnesh Lal, MSD
• Sundeep Kumar, Novartis
• Khomba Singh, Pfizer
• K.G. Ananthakrishnan, MSD and Vice President, OPPI
• Amitabh Baxi, Abbott
• Navin Sharma, Baxter
• Surbhi Chawla, BMS
• Sharad Goswami, Pfizer
• Khomba Singh, Pfizer
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
5 19.09.2014
6 30.09.2014
7 30.09.2014
8 01.10.2014
9 08.10.2014
10 10.10.2014
11 14.10.2014
37 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 3rd Part For Printing.indd 8 02/10/2015 4:06:20 PM
• Shri Ali Raza Rizvi Joint Secretary, MoHFW
• Dr V.K. Subburaj Secretary, DoP
• Shri Shailendra Kumar Director - Health, MoHWF
• Shri Ajay Shankar Secretary, NMCC
• Shri Sudhansh Pant Joint Secretary, DoP
• Officials from various ministries of Central Government
• Advisory Group Meeting CUTS International
• NLEM Core Committee
• Dr V.K. Subburaj Secretary, DoP
• Dr M. Ariz Ahammed Joint Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr Jagdish Prasad Director General, DGHS
• Dr G.N. Singh DCGI
• Shri A.K. Pradhan Dy DCI
• Shri R. Chandrashekhar Dy DCI
• Shri Arvind Kukrety Dy DCI
• Officials from CDSCO
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Gaurav Arya, Eli Lilly
• Sundeep Kumar, Novartis
• Sharad Goswami, Pfizer
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Tabrez Ahmad, OPPI
• Ranjana Smetacek, OPPI
• Nominated Members from the OPPI Finance & Taxation Committee
• Dr Shailesh Ayyangar, Sanofi and President, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Sameer Savkur, Biogen Idec and Vice President, OPPI
• Members of OPPI Medical & Regulatory Work Group
Courtesy call
Courtesy call
Regulatory issues, NLEM 2011, Clinical Trials
Discussions on the need for policies on New Drugs and the challenges on Make in India for the pharmaceutical industry
Business Responsibility Guidelines for the Pharmaceutical Sector
Participation in the National Consultation of NLEM 2011 revision
Issues related to pharmaceutical pricing and other challenges
Request to include OPPI in the Task Forces constituted by the DoP
Regulatory issues: PET Bottles and Clinical Trials approvals
12 15.10.2014
13 21.10.2014
14 29.10.2014
15 29.10.2014
16 30.10.2014
17 01.11.2014
18 03.11.2014
19 10.11.2014
20 12.11.2014
38
OPPI 2015 Final AW 3rd Part For Printing.indd 9 02/10/2015 4:06:20 PM
• Shri Jagdish Kumar Director, NPPA
• Shri S.S. Bisht Director, NIC
• NLEM Core Committee
• Dr Ahmed Kamal Director, NIPER
• Dr Srinivasan Nanduri NIPER
• Dr Shraddha Choudhary NIPER
• Dr Satyanarayanan NIPER
• Dr Jagdish Prasad Director General, DGHS
• Shri Kaushal Shrivastav Chairman, CBEC
• Officials from CBEC Department of Revenue
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Shri B.K. Singh Director, DoP
• Shri Ashish Banerjee Economic Officer, DIPP
• Prem Singh Rawat, OPPI
• Nominated Members from the OPPI Finance & Taxation Committee
• Vivek Padgaonkar, OPPI
• Dr Ramakrishnan Sundaram, BMS
• Amita Bhave, Novartis
• Yasmin Shenoy, Sanofi
• Prem Singh Rawat, OPPI
• Shirish Ghoge, Abbott
• Navin Sharma, Baxter
• Manish Vora, J&J
• Gaurav Karnik, E&Y
• Anupam Jain, KPMG
• Prem Singh Rawat, OPPI
• Tabrez Ahmad, OPPI
• Meenu Batolar, Biogen Idec
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Shirish Ghoge, Abbott
• Gaurav Karnik, Ernst & Young LLP
• Tarun Bhatnagar, Sanofi
• Prem Singh Rawat, OPPI
NPPA meeting with industry bodies on the Integrated Pharmaceutical Database Management System (IPDMS)
Participation in the National Consultation of NLEM 2011 revision
Industry Academia interaction
Matters related to PET bottles; local phase III data waiver for new drugs, new indications and line extensions
Ministry of Finance Pre-Budget meeting for Union Budget 2015-16
Meeting on DoP Task Force on Medical Devices
Meetings of the Task Force on e-Samiksha
Matters related to the NPPA notifications & National Consultation by NLEM Committee
OPPI Budget Proposal 2015-16
21 13.11.2014
22 16.11.2014
23 21.11.2014
24 24.11.2014
25 26.11.2014
26 27.11.2014
27 10.12.2014
28 10.12.2014
29 12.12.2014
39 ANNUAL REPORT 2014-15
OPPI 2015 Final AW 3rd Part For Printing.indd 10 02/10/2015 4:06:20 PM
• NLEM Core Committee
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP, Ministry of Commerce and CDSCO
• NLEM Core Committee
• Shri Sudhansh Pant Joint Secretary, DoP
• Officials from DoP Ministry of Commerce and CDSCO
• Shri Sudhansh Pant Joint Secretary, DoP
• Officials from DoP Ministry of Commerce and CDSCO
• Shri Amit Khare Member Secretary, NPPA
• Shri Sudhansh Pant Joint Secretary, DoP
• Ms Chandni Raina Director, DIPP
• Shri Jagdish Kumar Director, NPPA
• Shri Awadhesh K. Chaudhury Director, DoP
• Shri R Chandrashekhar Dy DCI
• Shri Raj Kumar Under Secretary, DoP
• Shri Awadhesh K. Chaudhury Director, DoP
• Nominated Members from the OPPI Finance & Taxation Committee
• Tabrez Ahmad, OPPI
• Tarun Bhatnagar, Sanofi
• Prem Singh Rawat, OPPI
• Nominated Members from the OPPI Finance & Taxation Committee
• Tarun Bhatnagar, Sanofi
• Prem Singh Rawat, OPPI
• Prem Singh Rawat, OPPI
• Khomba Singh, Pfizer
• Tabrez Ahmad, OPPI
• Sundeep Kumar, Novartis
• Shiv Prasad Laud, Roche
• Tarun Bhatnagar, Sanofi
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
Participation in the National Consultation of NLEM 2011 revision
2nd meeting of DoP Task Force on Medical Devices
Meeting of DoP Task Force on development of manufacturing capabilities in each medical vertical in pharmaceutical production
Participation in the National Consultation of NLEM 2011 revision
Meeting of the Task Force on e-Samiksha
Meeting of the sub-group of DoP Task Force on Medical Devices
Odisha Drug Inspectors restricting sale of certain cough syrups, citing DPCO provisions
Presentation on Patented Drugs Pricing Policy to the Inter-Ministerial Committee on Prices of Patented Drugs
Discussion on the sub-group on NCD under Task Force on Critical Medical Verticals
30 13.12.2014
31 18.12.2014
32 22.12.2014
33 29.12.2014
34 02.01.2015
35 02.01.2015
36 07.01.2015
37 08.01.2015
38 09.01.2015
40
OPPI 2015 Final AW 3rd Part For Printing.indd 11 02/10/2015 4:06:21 PM
• NLEM Core Committee
• Shri M. Zakaria Khan Yusufzai Sr. Development Officer, DIPP
• Officials from the Ministry of Commerce
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP and other Ministries
• Shri M. Zakaria Khan Yusufzai Sr. Development Officer, DIPP and other officials from the Ministry
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Members of IPR Think Tank
• Shri K.L. Sharma Joint Secretary, Department of Health, and officials from MoHFW
• Shri Sudhansh Pant Joint Secretary, DoP in Mumbai
• Nominated Members from the OPPI Finance & Taxation Committee
• Prabhat Jain, Abbott
• Navin Sharma, Baxter
• Prem Singh Rawat, OPPI
• Prabhat Jain, Abbott
• Navin Sharma, Baxter
• Prabhat Jain, Abbott
• Shilpa Arora, Merck Serono
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI • Sharad Tyagi, Boehringer Ingelheim and Vice President, OPPI
• Pravin Anand, Patent Attorney
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Meenu Batolar, Biogen Idec
• Dr Shailesh Ayyangar, Sanofi and President OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• K.G. Ananthakrishnan, MSD and Vice President, OPPI
• Bratin Bag, BMS
• Jayashree Shetty, J&J
• Ashish Vohra, Pfizer
• Ranjana Smetacek, OPPI
Participation in the National Consultation of NLEM 2011 revision
• Meeting of the sub-group of the Task Force for e–Samiksha: Industry Government Linkages.
• Meeting of the sub-group on high-end medical devices and pharmaceuticals manufacturing equipment
Meeting of DoP Task Force on Medical Devices
Meeting of the sub -group on high-end medical devices and pharmaceuticals manufacturing equipment
Regulatory issues related to pharmaceutical industry
Draft National IPR Policy consultations
Matters on Drugs & Cosmetics Amendment Bill
Follow up on the UCPMP
39 18.01.2015
40 19.01.2015
41 29.01.2015
42 03.02.2015
43 03.02.2015
44 05.02.2015
45 05.02.2015
46 10.02.2015
41 ANNUAL REPORT 2014-15
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• Shri Injeti Srinivas Chairman, NPPA
• Other NPPA Officials
• Shri Injeti Srinivas Chairman, NPPA
• Shri N.S. Kang Additional Secretary, Health & DG-CGHS
• NLEM Core Committee
• Dr G.N. Singh DCGI • Senior officials from CDSCO
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Atul Chaturvedi Joint Secretary, DIPP
• Dr Jagdish Prasad Director General, DGHS
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Shailendra Kumar Director, Health, MoHFW
• Tabrez Ahmad, OPPI
• Vivek Padgaonkar, OPPI
• Mehul Thakkar, J&J
• Vivek Dhariwal, Pfizer
• Sharad Goswami, Pfizer
• Khomba Singh, Pfizer
• Tarun Bhatnagar, Sanofi
• Prem Singh Rawat, OPPI
• Amitabh Baxi, Abbott
• Sharad Goswami, Pfizer
• Khomba Singh, Pfizer
• Tabrez Ahmad, OPPI
• Neelima Dwivedi, MSD
• Khomba Singh, Pfizer
• Ranjita Sood, Roche
• Tabrez Ahmad, OPPI
• Nominated Members from the OPPI Finance & Taxation Committee
• Dr Suresh Menon, Novartis
• Prem Singh Rawat, OPPI
• Dr Shailesh Ayyangar, Sanofi and President OPPI
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Dr Shailesh Ayyangar, Sanofi and President OPPI
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Dr Shailesh Ayyangar, Sanofi and President OPPI
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Prabhat Jain, Abbott
Issues related to the display of Distinguishing Mark and Ceiling Price/Unit in respect of Schedule Drugs under DPCO 2013
Odisha FDA’s restriction on sale of cough syrups under the provisions of DPCO 2013
Courtesy call
Participation in the National Consultation of NLEM 2011 revision
Meeting with the industry associations
DPCO 2013 & Pharmaceutical Policy
FDI in Pharmaceutical Industry
Regulatory issues
4th Meeting of the DoP Task Force on high-end Medical Devices and pharmaceutical manufacturing equipment
47 12.02.2015
48 13.02.2015
49 17.02.2015
50 18.02.2015
51 21.02.2015
52 24.02.2015
53 24.02.2015
54 24.02.2015
55 05.03.2015
42
OPPI 2015 Final AW 3rd Part For Printing.indd 13 02/10/2015 4:06:21 PM
• Dr Shailesh Ayyangar, Sanofi and President OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Angel-Michael Evangelista, Bayer and Member OPPI Executive Committee
• K. Shivkumar, Eisai and Member OPPI Executive Committee
• G. Sathya Narayanan, Galderma and Member OPPI Executive Committee
• Sanjiv Navangul, J&J and Member OPPI Executive Committee
• Dr Ramesh Panchagnula, Nektar and Member OPPI Executive Committee
• Aman Bajaaj, Takeda and Member OPPI Executive Committee
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Vivek Padgaonkar, OPPI
• Ajit Bendre, OPPI
• Dr Shailesh Ayyangar, Sanofi and President OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Aijaz Tobaccowalla, Pfizer and Vice President, OPPI
• Angel-Michael Evangelista, Bayer and Member OPPI Executive Committee
• K. Shivkumar, Eisai and Member OPPI Executive Committee
• G. Sathya Narayanan, Galderma and Member OPPI Executive Committee
• Sanjiv Navangul, J&J and Member OPPI Executive Committee
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Vivek Padgaonkar, OPPI
• Ajit Bendre, OPPI
Meeting of the OPPI Executive Committee members with NIPER
Meeting of the OPPI Executive Committee members with Government of Punjab at Invest Punjab, Chandigarh
56 11.03.2015
57 12.03.2015
• Prof K.K. Bhutani Director (Offg.), NIPER, Mohali, Punjab - Meetings organised at the behest of Punjab Government and facilitated by KPMG
• Shri Sukhbir Singh Badal Deputy Chief Minister of Punjab
• Dr Karan Avtar Singh Principal Secretary, Investment Promotion
• Shri Anirudh Tewari CEO, Invest Punjab
• Officials from Invest Punjab
• Utkarsh Palnitkar KPMG
43 ANNUAL REPORT 2014-15
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• Shri Ananth Kumar Hon’ble Minister of Chemicals & Fertilizers
• Dr V.K. Subburaj Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Senior officials of the Ministry
• Dr Harshadeep Kamble Commissioner FDA, Maharashtra
• Shri Injeti Srinivas Chairman, NPPA in Mumbai
• Shri Injeti Srinivas Chairman, NPPA in Mumbai
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Amit Khare Member Secretary, NPPA
• Shri Jagdish Kumar Director, NPPA
• Shri R.K. Maggo Director, DoP
• Officials from DoP
• Dr Harshadeep Kamble FDA Commissioner, Maharashtra
• Shirish Ghoge, Abbott
• Sudarshan Jain, Abbott and Vice President, OPPI
• Shirish Ghoge, Abbott
• Dharmesh Kharwar, MSD
• Sadhana Mogre, Sanofi
• Krishna Parab, Sanofi
• Ranjana Smetacek, OPPI
• Rajiv Shukla, OPPI
• Dr Ajay Sharma, OPPI
• Shirish Ghoge, Abbott
• Ranjana Smetacek, OPPI
• Vivek Padgaonkar, OPPI
• Jitendra Tyagi, BMS and Member OPPI Executive Committee
• G. Sathya Narayanan, Galderma and Member OPPI Executive Committee
• Shirish Ghoge, Abbott
• Giri Giridhar, MSD
• Varun Gupta, Novartis
• Ranjana Smetacek, OPPI
• Vivek Padgaonkar, OPPI
• Vishal Maheshwari, Abbott
• Manish Vora, J&J
• Khomba Singh, Pfizer
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Other Industry Associations
• Shirish Ghoge, Abbott
• Ashish Jain, Abbott
• Suresh Nair, Ernst & Young LLP
• Krishan Parab, Sanofi
Launch of Jan Samadhan and release of NPPA Compendium – 2015
Industry interaction with new FDA Commissioner, Maharashtra
Issues of Implementation of DPCO 2013
Industry issues
To discuss proposals for amendment in DPCO 2013
Follow-up on meeting of March 17, 2015
58 12.03.2015
59 17.03.2015
60 18.03.2015
61 19.03.2015
62 25.03.2015
63 26.03.2015
44
OPPI 2015 Final AW 3rd Part For Printing.indd 15 02/10/2015 4:06:21 PM
• Dr V.M. Katoch former DG - ICMR & Secretary, Dept. of Health Research
• Dr Jagdish Prasad Director General, DGHS
• Dr Y.K. Gupta Head & Professor, Dept. of Pharmacology, AIIMS
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Officials from DoP
• Shri Rajiv Aggarwal Joint Secretary, DIPP
• Ms Chandni Raina Director, DIPP
• Shri R. Chandrashekhar Dy DCI
• Ranjana Smetacek, OPPI
• Rajiv Shukla, OPPI
• Dr Ajay Sharma, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Shirish Ghoge, Abbott
• Sharad Goswami, Pfizer
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Sharad Goswami, Pfizer
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Shirish Ghoge, Abbott
• Sharad Goswami, Pfizer
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Shirish Ghoge, Abbott
• Sharad Goswami, Pfizer
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Shirish Ghoge, Abbott
• Sharad Goswami, Pfizer
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Tabrez Ahmad, OPPI
• Ms Meenu Batolar, Biogen Idec
Matters related to NLEM and Access to Healthcare
Regulatory issues and PET bottles
Matters related to NLEM and Access to Healthcare
• Regulatory issues: D&C Bill, PET bottles ban
• NLEM 2011
Issues related to Pricing/DPCO 2013/NLEM 2011
To chalk out calender of events/programmes to be organised in partnership with DoP
Courtesy meeting
IPR issues
Discussion on e-Governance and
64 30.03.2015
65 30.03.2015
66 31.03.2015
67 31.03.2015
68 31.03.2015
69 01.04.2015
70 06.04.2015
71 06.04.2015
72 10.04.2015
45 ANNUAL REPORT 2014-15
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• PHD Chamber Core Group Vision 2020 for Pharma & Medical Devices Sector
• Dr G.N. Singh DCGI
• Dr Eswara Reddy Joint DCI
• Dr V.K. Subburaj Secretary, DoP
• Dr Jagdish Prasad Director General, DGHS
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr. Sanjay Jaiswal MP of BJP
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Dr Subhash Bhamre BJP, MP
• Dr G.N. Singh DCGI
• Rishi Kapur, BMS
• Dr Lakhvinder Singh Batolar, J&J
• Ranjana Smetacek, OPPI
• Rishi Kapur, BMS
• Dr Lakhvinder Singh Batolar, J&J
• Ketan Kotadiya, Roche
• Gopinath Balaji, Quintiles
• Tabrez Ahmad, OPPI and Representatives of Indian Association of Dermatology, Leprology and Venerology
• Shirish Ghoge, Abbott
• Jayasree Menon, GSK
• Khomba Singh, Pfizer
• Kedar Suvarnapathaki, Bohringer-Ingleheim
• Vinod Mattoo, BMS
• Rahul Chauhan, Eli Lilly
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Dr Shashwati Pramanik, Amgen
• Dr Ramakrishnan Sundaram, BMS
• Rahul Chauhan, Eli Lilly
• Amita Bhave, Novartis
• Yasmin Shenoy, Sanofi
• Tabrez Ahmad, OPPI
• Tabrez Ahmad, OPPI
• Dr Veena Jaguste, Amgen
• Dr Viraj Suvarna, Boehringer Ingelheim
• Rahul Chauhan, Eli Lilly
• Dr Suresh Menon, Novartis
Digitisation of services at CDSCO
Discussion to formulate the vision for Pharma and Medical Devices Sector
Discussion on e-Governance and digitalisation of services at CDSCO
Discussion on Patient Safety
Proposals for amendment of DPCO 2013
• D&C Amendment Bill & Rules
• Clinical Trials waiver for life threatening diseases
• 3 trial site per investigator
• Clarity on Subject Expert Committee (SEC)
Discussion on healthcare policies
• Import related issues & Rule 37
• National Institute of Biologicals NIB Testing issue
73 10.04.2015
74 13.04.2015
75 24.04.2015
76 06.05.2015
77 06.05.2015
78 08.05.2015
79 12.05.2015
80 13.05.2015
46
OPPI 2015 Final AW 3rd Part For Printing.indd 17 02/10/2015 4:06:21 PM
• Shri Bhanu Pratap Sharma Secretary, Department of Health, MoHFW
• Shri Hansraj Gangaram Ahir Minister of State for Chemicals & Fertilizers
• Dr M. Ariz Ahammed Joint Secretary, DoP
• Shri Arvind Kumar Principal Secretary to Government of Maharashtra
• Shri Amitabh Kant Secretary, DIPP
• Shri Rajiv Aggarwal Joint Secretary, DIPP
• Shri Ananth Kumar Minister for Chemicals & Fertilizers
• Shri Hansraj Gangaram Ahir Minister of State for Chemicals & Fertilizers
• Senior officials of DoP
• Suneela Thatte, Quintiles
• Yasmin Shenoy, Sanofi
• Tabrez Ahmad, OPPI
• Dr Veena Jaguste, Amgen
• Dr Viraj Suvarna, Boehringer Ingelheim
• Rahul Chauhan, Eli Lilly
• Dr Suresh Menon, Novartis
• Suneela Thatte, Quintiles
• Tabrez Ahmad, OPPI
• Dr Shailesh Ayyangar, Sanofi and President, OPPI
• Sharad Tyagi, Boheringer Ingelheim and Vice President OPPI
• K.G. Ananthakrishnan, MSD and Vice President OPPI
• Aman Bajaaj, Takeda and Member OPPI Executive Committee
• Pushpak Khare, Abbott
• N. V. Challapathi Rao, Bayer
• Ranjana Smetacek, OPPI
• Vivek Padgaonkar, OPPI
• Dr Ajay Sharma, OPPI
• Tabrez Ahmad, OPPI
• A joint industry delegation
• Angel-Michael Evangelista, Bayer and Member OPPI Executive Committee
• Tabrez Ahmad, OPPI
• Tabrez Ahmad, OPPI
• Dr Shailesh Ayyangar, Sanofi and President, OPPI
• Ranjit Shahani, Novartis and Immediate Past President, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Clinical Trial waiver for life - threatening diseases
Drugs & Cosmetics Amendment Bill and Rules
Discussion on industry issues
NIPER Meeting at Guwhati
Issue of fixed working hours of the medical representatives
Discussions on issues related to IPR
Discussions on issues related to IPR
• NIPERs
• NLEM 2011
• DPCO 2013
81 13.05.2015
82 13.05.2015
83 19.05.2015
84 22.05.2015
85 26.05.2015
86 27.05.2015
87 30.05.2015
47 ANNUAL REPORT 2014-15
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• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Dr G.N. Singh, DCGI
• Shri A.K. Pradhan Dy Drugs Controller (I)
• Dr Ranjit Roy Chaudhury Chairman – Expert Committee to Formulate Policy Guidelines & SOPs for Approval of New Drugs, Clinical Trials & Banning of New Drugs
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr V.G. Somani Joint Drugs Controller (I)
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Shri Shailendra Kumar Director, Health, MoHFW
• Dr V.G. Somani Joint Drugs Controller (I)
• Shri Sudhansh Pant Joint Secretary, DoP
• Senior Officials
• Shri Jagdish Kumar Director, NPPA
• Ms Shobha Mishra Ghosh FICCI
• Shri D Sengupta CII
• Shri Ombeer Tyagi ASSOCHAM
• Sharad Tyagi, Boehringer Ingelheim and Vice President, OPPI
• K.G. Ananthakrishnan, MSD and Vice President, OPPI
• Ranjana Smetacek, OPPI
• Members of OPPI Medical and Regulatory Work Group
• NGOs and other stakeholders
• Dhritiman Biswas, Abbott
• Sharad Goswami, Pfizer
• Khomba Singh, Pfizer
• Tabrez Ahmad, OPPI
• Dr Rishi Kapur, BMS
• Dr Lakhvinder Singh Batolar, J&J
• Amit Mookim, IMS
• Tabrez Ahmad, OPPI
• Dr Ajay Sharma, OPPI
• Anirban Roychowdhary, Merck
• Shirish Ghoge, Abbott
• Khomba Singh, Pfizer
• Amit Mookim, IMS
• Tabrez Ahmad, OPPI
• Dr Ajay Sharma, OPPI
Regulatory issues
Related to Odisha Drugs Controller’s restriction on sale of cough syrups
Amendments to Drugs & Cosmetics Rules,1945, pertaining to drugs
Discussion on the Study - Access and Affordability in India - Assess the Impact of Price Control Measures
Amendments to Drugs & Cosmetics Rules, 1945, pertaining to clinical trials
Amendments suggested in DPCO-2013
Discussion on the Study - Access and Affordability in India - Assess the Impact of Price Control Measures
88 30.05.2015
89 04.06.2015
90 05.06.2015
91 08.06.2015
92 08.06.2015
93 09.06.2015
94 09.06.2015
48
OPPI 2015 Final AW 3rd Part For Printing.indd 19 02/10/2015 4:06:21 PM
• Shri Sudhanshu Pandey Joint Secretary, Department of Commerce
• Shri Anurag Jain Joint Secretary, Prime Minister’s Office
• Dr K. Bangarurajan Dy Drugs Controller (India) DGHS, SDSCO, West Zone
• Dr Sharmila Mary Joseph Member Secretary, NPPA
• Senior officials of NPPA
• Dr V.G. Somani Joint Drugs Controller (I)
• Senior officials of CDSCO
• Shri Manoj Jhalani Joint Secretary, MoHFW
• Shri Anshu Prakash Joint Secretary, MoHFW
• Shri Amitabh Kant Secretary, DIPP
• Shri Ananth Kumar Minister for Chemicals & Fertilizers
• Shri Hansraj Gangaram Ahir Minister of State for Chemicals & Fertilizers
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary
• Senior officials of DoP
• Shri Ananth Kumar Minister for Chemicals & Fertilizers
• Amit Mookim, IMS
• Tabrez Ahmad, OPPI
• Dr Ajay Sharma, OPPI
• Tabrez Ahmad, OPPI
• Dr Ajay Sharma, OPPI
• Sachin Sable, MSD
• Amita Bhave, Novartis
• Sofia Braganza, Pfizer
• Yasmin Shenoy, Sanofi
• Vivek Padgaonkar, OPPI
• Tabrez Ahmad, OPPI
• Meenu Batolar, Biogene Idec
• Rishi Kapur, BMS
• Dr Lakhvinder Singh Batolar, J&J
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Tabrez Ahmad, OPPI
• Prem Singh Rawat, OPPI
• Dr Shailesh Ayyangar, Sanofi and President OPPI
Discussion on the Study - Access and Affordability in India - Assess the Impact of Price Control Measures
Discussion on the Study - Access and Affordability in India - Assess the Impact of Price Control Measures
Issue pertaining to Form 11 Export and Import NOCs and other related matters.
Discussions on the Odisha Drugs Controller’s restriction on sale of cough syrups.
Meeting on amendments to Drugs & Cosmetics Rules, 1945 pertaining to drugs
Regulatory and Healthcare issues
IP and FDI Issues
Launch of the Report of the Task Force on e-Samiksha
Launch of Pharma Price Data Bank (PPDB) – IPDMS
95 10.06.2015
96 10.06.2015
97 10.06.2015
98 11.06.2015
99 11.06.2015
100 12.06.2015
101 12.06.2015
102 22.06.2015
103 25.06.2015
49 ANNUAL REPORT 2014-15
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• Shri V.K. Subburaj Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Senior officials of DoP
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr Mohd. Shaukat Usta Dy DG, DGHS
• Dr Alka Sharma Department of Biotechnology
• Shri Raj Kumar Under Secretary, DoP
• Dr Mohd. Shaukat Usta Dy DG, DGHS
• Dr Sharmila Mary Joseph Member Secretary, NPPA
• Officials of NPPA
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP and officials from the Department
• Shri Hansraj Gangaram Ahir Minister of State for Chemicals & Fertilizers
• Shri Sudhansh Pant Joint Secretary, DoP,
• Officials from the NPPA and CDSCO
• Shri Mohapatra Odisha Drugs Controller
• Shri V.K. Subburaj Secretary, DoP
• Ranjit Shahani, Novartis and Immediate Past President, OPPI
• Shirish Ghoge, Abbott
• Ranjita Sood, Roche
• Tarun Bhatnagar, Sanofi
• Prem Singh Rawat, OPPI
• Ranjita Sood, Roche
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Shirish Ghoge, Abbott
• Sanchit Nanda, Novartis
• Khomba Singh, Pfizer
• Amit Mookim, IMS
• Tabrez Ahmad, OPPI
• Shirish Ghoge, Abbott
• Sharad Goswami, Pfizer
• Sudarshan Jain, Abbott and Vice President, OPPI
• Tabrez Ahmad, OPPI
• Dhritiman Biswas, Abbott
• Khomba Singh, Pfizer
• Tabrez Ahmad, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
Meeting of the Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production
Sub-group on NCDs under Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production
Matters related to high margins in retail marketing of ‘traded generic medicines’
Discussion on the Study - Access and Affordability in India - Assess the Impact of Price Control Measures
Meeting on amendments in DPCO 2013
Meeting to invite for the OPPI Fourth Healthcare Access Summit
Matters related to Codeine-based cough syrups issue with Odisha Drug Authorities
Meeting to invite for the OPPI Fourth Healthcare
104 01.07.2015
105 03.07.2015
106 14.07.2015
107 14.07.2015
108 15.07.2015
109 21.07.2015
110 21.07.2015
111 22.07.2015
50
OPPI 2015 Final AW 3rd Part For Printing.indd 21 02/10/2015 4:06:21 PM
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr Mohd. Shaukat Usta Dy DG, DGHS
• Shri Bibek Debroy Member, Niti Aayog
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Sanjiv Kumar ADCI, CDSCO
• Ms Barnali Khastgir Under Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Ananth Kumar Minister for Chemicals & Fertilizers
• Dr V.K. Subburaj Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Officials from DoP
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Ranjita Sood, Roche
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
• Sudarshan Jain, Abbott and Vice President, OPPI
• Shirish Ghoge, Abbott
• Ranjana Smetacek, OPPI
• K.G. Ananthakrishnan, MSD and Vice President, OPPI
• Neelima Dwivedi, MSD
• Tabrez Ahmad, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Arun Mishra, Abbott
• Shripal Sharma, Bayer
• Prem Singh Rawat, OPPI
• Representative from IPA
• Tabrez Ahmad, OPPI
• Ranjana Smetacek, OPPI
• Tabrez Ahmad, OPPI
• Ranjita Sood, Roche
• Tarun Bhatnagar, Sanofi
• Tabrez Ahmad, OPPI
Access Summit
Sub-group on NCDs under Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production
Meeting to invite for the OPPI Fourth Healthcare Access Summit
Meeting to invite for the OPPI Ethics and Compliance Conclave
Related to DPCO issues
Challenges faced in acceptance of GMP certificate
Related to Odisha FDA’s restrictions on sale of Codeine base formulations / SC Order
Meeting called by Hon’ble Minister of Chemicals & Fertilizers on the UCPMP
Task Force for development of manufacturing capabilities in each medical vertical in pharmaceutical production
112 22.07.2015
113 22.07.2015
114 22.07.2015
115 23.07.2015
116 24.07.2015
117 28.07.2015
118 29.07.2015
119 31.07.2015
51 ANNUAL REPORT 2014-15
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• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Dr V.G. Somani
Joint Drugs Controller (India)
• Dr Sharmila Mary Joseph Member Secretary, NPPA
• Officials from NPPA
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Officials from NPPA
• Dr V.K. Subburaj Secretary, DoP
• Officials from DoP
• Shri K.L. Sharma Joint Secretary, Department of Health, MoHFW
• Dr G.N. Singh DCGI
• Prabhat Jain, Abbott
• Tabrez Ahmad, OPPI
• Other Industry Associations
• Amita Bhave, Novartis
• Yasmin Shenoy, Sanofi
• Prem Singh Rawat, OPPI
• Shirish Ghoge, Abbott
• Khomba Singh, Pfizer
• Other Industry Associations
• Shrisih Ghoge, Abbott
• Shubhra Thakur, MSD
• Other Industry Associations
• Prem Singh Rawat, OPPI
• Other Industry Associations
• Tabrez Ahmad, OPPI
• Other Industry Associations
• Dr Shashwati Pramanik, Amgen
• Rahul Chauhan, Eli Lilly
• Dr Suresh Menon, Novartis
• Suneela Thatte, Quintiles
• Dr Shashwati Pramanik, Amgen
• Rahul Chauhan, Eli Lilly
• Dr Suresh Menon, Novartis
• Suneela Thatte, Quintiles
• Tabrez Ahmad, OPPI
Matters related to the medical devices sector
Import issues in case of change of registration certificate
Discussion on the IPDMS and its functioning
Issues related to optimum capacity utilisation of Bulk Drugs/APIs
Trade Margins
India Pharma Awards
Regulatory issues
Regulatory issues
120 04.08.2015
121 07.08.2015
122 11.08.2015
123 11.08.2015
124 14.08.2015
125 26.08.2015
126 28.08.2015
127 28.08.2015
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OPPI 2015 Final AW 3rd Part For Printing.indd 23 02/10/2015 4:06:22 PM
• Shri Jagdish Kumar Director (Monitoring), NPPA
• Ms Aradhana Johri Secretary, DoP
• Ms Barnali Khastgir Under Secretary, DoP
• Shri Jagdish Kumar Director (M&E), NPPA
• Shri Jagdish Kumar Director (M&E), NPPA • Shri Injeti Srinivas Chairman, NPPA
Date Subject Addressed to
Ministry Representations
1 18.08.2014
2 03.09.2014
3 18.09.2014
4 24.09.2014
5 25.09.2014
Comments on the draft NPPA guidelines for discontinuation of Scheduled Formulations under Para 21(2) of DPCO, 2013
Pre-Budget Memorandum 2015-16
• Recommendations on the draft NPPA guidelines for discontinuation of Scheduled Formulations under Para 21(2) of DPCO, 2013
• Comments on the draft Internal Guidelines for dealing with cases of Price Revision under Para 19 of DPCO, 2013
Benefit of excise notification to be extended for Non-Scheduled Formulations covered under Para 19
Fixing of prices of products included in the Scheduled category under DPCO 1995 and DPCO 2013
1 Ministry of Chemicals & Fertilizers (DoP, NPPA) 31
2 Ministry of Health & Family Welfare / CDSCO / IPC / FDA 38
3 Ministry of Commerce & Industry 8
4 Ministry of Finance 12
5 Ministry of Labour & Employment 3
6 Others 5
Total: 97
Representations 2014-15w.e.f. August 16, 2014
Summary:
MINISTRY OF CHEMICALS & FERTILIZERS (Department of Pharmaceuticals – DoP and National Pharmaceutical Pricing Authority - NPPA)
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• Shri A.K. Chaudhury Director, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Dr V.K. Subburaj Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Dr V.K. Subburaj Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Dr V.K. Subburaj Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Shri A.K. Chaudhury Director, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Dr V.K. Subburaj Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Dr M. Ariz Ahammed Joint Secretary, DoP
• Shri Shyam Agrawal Assistant Director (M&E), NPPA
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr V.M. Katoch Chairman, Core Committee on Revision of NLEM 2011
6 17.10.2014
7 22.10.2014
8 22.10.2014
9 04.11.2014
10 05.11.2014
11 27.11.2014
12 28.11.2014
13 28.11.2014
14 28.11.2014
15 12.12.2014
16 19.12.2014
17 30.01.2015
18 12.02.2015
19 20.02.2015
Comments on detailed project report on Investment in Innovative Pharma: Establishing Pharma Funds
Integrated Pharmaceutical Database Management System (IPDMS)
Price reduction to be prospective instead of retrospective
Internal guidelines for soliciting representation to NPPA against price notification, without prejudice
OPPI’s inclusion in the newly constituted Task Forces of DoP
Comments on the draft proposal for display of distinguishing mark and ceiling price/unit in respect of Scheduled Drugs under DPCO 2013
Demand assessment for GLP compliant testing labs for pharmaceutical sector
Discrepancies noted/rectification proposed for National List of Essential Medicines (NLEM) 2011
Uniform Code of Pharmaceutical Marketing Practices (UCPMP)
Comments on public notice dated November 21, 2014 with respect to inclusion of certain anti-cancer drugs in NLEM 2011
OPPI’s partnership with DoP
Response to NPPA’s request for information on patented drugs from OPPI member companies
Suggestions on the UCPMP
Revision of the NLEM 2011
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• Dr V.K. Subburaj Secretary, DoP
• Shri Shyam S Agrawal Asst. Director (M&E), NPPA
• Dr V.K. Subburaj Secretary, DoP
• Shri Ananth Kumar Hon’ble Minister for Chemicals & Fertilizers
• Shri Injeti Srinivas Chairman, NPPA
• Shri Injeti Srinivas Chairman, NPPA
• Shri Ananth Kumar Hon’ble Minister for Chemicals & Fertilizers
• Dr V.K. Subburaj Secretary, DoP
• Shri Raj Kumar Under Secretary, DoP
• Shri Raj Kumar Under Secretary, DoP
• Shri Sudhansh Pant Joint Secretary, DoP
• Shri Injeti Srinivas Chairman, NPPA
• Shri Sudhansh Pant Joint Secretary, DoP
• Dr V.K. Subburaj Secretary, DoP
20 02.03.2015
21 06.04.2015
22 14.04.2015
23 29.05.2015
24 02.06.2015
25 04.06.2015
26 22.06.2015
27 26.06.2015
28 30.06.2015
29 10.08.2015
30 18.08.2015
31 28.08.2015
Information on patented drugs from OPPI member companies
DPCO 2013 Amendment – OPPI’s recommendations
Revision of the NLEM 2011
DPCO 2013 – regarding notification S.O. 932(E) dated March 27, 2014
Amendment to DPCO 2013 - regarding notification S.O. 686(E) dated March 09, 2015
Revision of the NLEM 2011
Amendment in the DPCO 2013
Comments / suggestions on the draft National Medical Device Policy 2015
OPPI comments on the Proposed Amendment in DPCO, 2013 from NPPA
Challenges while using the IPDMS
Comments on the suggestions from NPPA in respect of Proposed Amendment in DPCO, 2013
Comments on NPPA’s recommendations to the Government on trade margins
• Dr G.N. Singh DCGI
Date Subject Addressed to
1 18.08.2014 Comments on proposal for creation of IT enabled system for Clinical Trials
MINISTRY OF HEALTH & FAMILY WELFARE (MoHFW) / CDSCO
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• Dr A.K. Panda Additional Secretary, MoHFW
• Dr G.N. Singh Drugs Controller General (India)
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri Hrushikesh Mahapatra, Dy. Drugs Controller (Int) & D.C.(O) i/c, Office of the Directorate of Drugs Control Odisha
• Ms Arti Ahuja Commissioner cum Secretary (Health & FW) Department of Health & Family Welfare Government of Odisha
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Dr G.N. Singh DCGI
• Dr G.N. Singh DCGI
• Shri J.P. Nadda Hon’ble Minister of Health & Family Welfare
• Shri Deepak Kumar Principal Secretary, Ministry of Health Government of Bihar
• Prof Ranjit Roy Chaudhury Advisor, MoHFW
• Dr Shailendra Kumar Director (Drugs), MoHFW
• Ms Anita Tripathi Under Secretary, MoHFW
• Ms Anita Tripathi Under Secretary (Drugs), MOHFW
• Dr. G.N. Singh DCGI
3 27.08.214
4 23.09.2014
5 27.10.2014
6 04.11.2014
7 04.11.2014
8 10.11.2014
9 11.11.2014
10 14.11.2014
11 05.12.2014
12 22.12.2014
Suggestions on GSR 503(E) dated July 14, 2014 regarding amendment of Rule 105 of the Drugs & Cosmetics Rules, 1945
Guidelines dated August 20, 2014 passed by the Odisha State Drug Department in respect of sale of drugs in Odisha
Streamlining regulatory processes of the pharmaceutical industry
Draft notification GSR 701(E) dated September 29, 2014 regarding banning PET bottles in specific uses
Action against unethical practices in pharmaceutical marketing
Submission emphasising priorities to support the healthcare objectives and revitalise the pharmaceutical industry
To revoke the recent Order imposed on the sale of codeine-based cough syrups in Bihar
Draft notification GSR 701(E) dated September 29, 2014 regarding banning PET bottles in specific uses
Amendment in Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
Comments on the strengthening of drug regulatory framework in India viz. (i) CDSCO and (ii) States’ drug regulatory system
• Shri Deepak Kumar Principal Secretary, Ministry of Health Government of Bihar
2 22.08.2014
To revoke the recent Order imposed on sale of codeine-based cough syrups in Bihar
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• Ms Anita Tripathi Under Secretary (Drugs), MOHFW
• Shri Shailendra Kumar Director (Drugs), MoHFW
• Ms Anita Tripathi Under Secretary (Drugs), MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Dr. G.N. Singh DCGI
• Dr G.N. Singh DCGI
• Shri J.P. Nadda, Hon’ble Minister of Health & Family Welfare
• Dr V.M. Katoch Former Secretary, Department of Health Research & Director General, ICMR
• Dr Y.K. Gupta Professor & Head, Department of Pharmacology, AIIMS
• Shri K.L. Sharma Joint Secretary, MoHFW
• Dr V.K. Subburaj, Secretary, DoP
• Shri K.L. Sharma, Joint Secretary, MoHFW
• Dr Mohd. Shaukat Usta Deputy Director General (NCD), DGHS, MoHFW
13 12.01.2015
14 16.01.2015
15 28.01.2015
16 02.02.2015
17 11.02.2015
18 02.04.2015
19 14.04.2015
20 23.04.2015
21 13.05.2015
22 18.05.2015
Constitution of a committee for examining and recommending amendment in the Drugs & Cosmetics Rules, 1945
Comments and suggestions on the draft Drugs & Cosmetics (Amendment) Bill, 2015
Comments and suggestions regarding amendment in the Drugs & Cosmetics Rules, 1945
Follow up on meeting of the sub-group on regulatory issues under the Task Force on promotion of domestic production of high-end medical devices and pharmaceutical manufacturing equipment in the country
CDSCO’s notice on pre-submission meetings – (regulatory pathways)
OPPI recommendations on Test Import License Validity (for drugs imported for use in Form 11 for examination/test/analysis)
Revision of the NLEM 2011
Exemption of low priced drugs from price control
Position paper on the working of Genetic Engineering Appraisal Committee (GEAC)
Submission of the final report to sub-group on Non-Communicable Diseases (NCDs) under the Task Force ‘Development of Capabilities for Each Medical Vertical’
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• Shri Bhanu Pratap Sharma Secretary, MoHFW
• Dr G.N. Singh DCGI
• Dr G.N. Singh, DCGI
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri R. Chandrashekhar Deputy Drugs Controller (India)
• The Under Secretary, MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Shri K.L. Sharma Joint Secretary, MoHFW
• Dr G.N. Singh DCGI
• Dr G.N. Singh DCGI
• Shri Bhanu Pratap Sharma Secretary, MoHFW
23 18.05.2015
24 18.05.2015
25 21.05.2015
26 09.06.2015
27 24.06.2015
28 01.07.2015
29 02.07.2015
30 10.07.2015
31 17.07.2015
32 20.07.2015
33 21.07.2015
34 22.07.2015
35 05.08.2015
36 05.08.2015
Follow up on the May 13, 2015 interaction with the Medical & Regulatory WG
Follow up on the May 13, 2015 interaction with thre Medical & Regulatory WG
Follow up letter regarding regulatory issues
Follow up letter regarding regulatory issues
Position on consideration of local Clinical Trials (CTs) data waiver for life-threatening diseases
Training of CDSCO Inspectors
Import issues in case of change in Registration Certificate
Meeting on the Amendment in the Drugs & Cosmetics Rules, 1945 pertaining to drugs, held on June 11, 2015
Notification dated June 03, 2015 regarding draft rules to amend the Drugs and Cosmetics Rules, 1945, in Rule 96, in sub-rule (1) G.S.R. 449 (E) – F.No. 02/Misc./2010-DC/DFQC
Grievances of the clinical research fraternity on the restrictive limit on the number of CTs (not more than 3) that may be conducted by an investigator and proposal to amend the limit with justification
Position paper on the current DCGI practice of Registration of multiple site involved in a single imported product
CDSCO’s Notice dated June 04, 2015 - regulatory compliance of drugs imported into the country
Office notice dated July 22, 2015 DCG(I)/Misc.2015 (132) in context of permission obtained from DCGI for new drugs, CTs on bioavailability/bioequivalence studies
Imported Drugs: Implementation of physical verification and testing of all the
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• Dr V.G. Somani Joint Drugs Controller (India)
• Shri Ali Rizvi Joint Secretary, Medical Education, MoHFW
37 11.08.2015
38 18.08.2015
drug products at Mumbai air and sea ports from July 2015
Import issues in case of change of Registration Certificate (follow up of interaction with Dr V.G. Somani)
Rational prescription of drugs and use of ‘Generic Names’
• Shri Rajeev Kher Secretary, Department of Commerce
• Shri Amitabh Kant Secretary, Department of Industrial Policy & Promotion (DIPP)
• Justice Prabha Sridevan Chairperson, IPR Think Tank
• Shri Atul Chaturvedi Joint Secretary, DIPP
• Shri Ishtiyaque Ahmed Director, DIPP
• Smt Nirmala Sitharaman Hon’ble Minister of State for Commerce & Industry (Independent Charge)
• Shri Atul Chaturvedi Joint Secretary, DIPP
• Shri Ishtiyaque Ahmed Director, DIPP
• Justice (Retd.) Prabha Sridevan Chairperson, IPR Think Tank
• Shri Narendra K. Sabharwal Convener Member, IPR Think Tank
• Shri Amitabh Kant Secretary, DIPP
1 17.09.2014
2 29.10.2014
3 28.11.2014
4 16.12.2014
5 18.12.2014
6 14.01.2015
7 30.01.2015
8 02.03.2015
Challenges faced by the research-based pharmaceutical industry in India
IPR Think Tank constituted by the DIPP
Public Notice dated November 13, 2014 seeking comments in respect of the proposed National IPR Policy
Mapping of the activities covered under Chapter VI of the consolidated Foreign Direct Investment (FDI) Policy, 2014 using NIC – 2008 codes
IPR Think Tank constituted by the DIPP
Views and suggestions on the consolidated FDI Policy circular 2015
Feedback on the draft National IPR Policy
Revision of the NLEM 2011
Date Subject Addressed to
MINISTRY OF COMMERCE & INDUSTRY
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MINISTRY OF FINANCE (MoF)
• Shri S.K. Shrivastava Additional Chief Secretary Finance Department, Government of Maharashtra
• Secretary Department of Finance & Revenue, MoF
• Chairman Central Board of Excise & Customs
• Joint Secretary Tax Policy & Legislation (TPL), Central Board of Direct Taxes
• Joint Secretary (TRU-1)
• Shri Arun Jaitley Hon’ble Finance Minister
• Shri Sanjay Aggarwal Director, Public Procurement Division (PPD), Department of Expenditure, MoF
• Shri Jayant Sinha Hon’ble Minister of State for Finance
• Finance Secretary Department of Economic Affairs, MoF
• Secretary Department of Revenue, MoF
• The Commissioner (NC) Department of Revenue, MoF
• Director (Tax Policy & Legislation) Central Board of Direct Taxes
1 19.08.2014
2 03.09.2014
3 14.04.2015
4 15.04.2015
5 18.04.2015
6 29.04.2015
7 21.05.2015
8 29.05.2015
Recommendations on draft MVAT (Second Amendments) Rules, 2014 in relation to procedures/compliances for the issuance of e-waybill and transit pass
Pre-Budget Memorandum 2015-16
Revision of the NLEM 2011
Suggestions/comments on Public Procurement Bill - stakeholders consultations Revision of the NLEM 2011
Recommendations : Post Union Budget 2015-16
Voluntary Code of Conduct (VCC) to NDPS (Regulation of Controlled Substance) Order, 2013
Comments on draft scheme of the Proposed Rules for computation of Arm Length Price (ALP) of an international transaction or specified domestic transaction
Date Subject Addressed to
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• Shri Prakash Manchhubhai Mehta Hon’ble Minister of Labour Government of Maharashtra
• Shri Vijay Sidramappa Deshmukh Hon’ble Minister of State for Labour, Government of Maharashtra
• Shri Baldev Singh Principal Secretary Department of Labour Government of Maharashtra
• The Chief Labour Office Department of Labour Government of Tripura
1 12.02.2015
2 03.06.2015
3 04.06.2015
Objection to notification G.N.No. SPE-2010/C.R. 143/Lab-3 dated January 15, 2014 issued by Labour Department, Maharashtra on the fixing working hours for the sales promotion employees
Meeting with the Industry delegation on May 22, 2015 regarding issues with fixing working hours for the sales promotion employees
Objection to the notification No. F.12(48)LAB/IR/2009/11607-21 dated September 06, 2014, Labour Directorate, Government of Tripura on fixing working hours for the sales promotion employees (Jointly by OPPI & IDMA)
Date Subject Addressed to
MINISTRY OF LABOUR & EMPLOYMENT
• Shri Jayant Sinha Hon’ble Minister of State for Finance
• Ms Rashmi Verma Additional Secretary (Revenue) Department of Revenue, MoF
• Finance Secretary Department of Economic Affairs, MoF
• Revenue Secretary Department of Revenue, MoF
• Ms Rashmi Verma Additional Secretary (Revenue) Department of Revenue, MoF
9 01.06.2015
10 22.06.2015
11 05.08.2015
12 18.08.2015
FDI : Impact on the research-based pharmaceutical industry in India
Clarification on invitation of BIDs / proposals for production of concentrate of poppy straw & manufacture of Alkaloids
Suggestions on the Goods and Services Tax (GST)
Further clarification on invitation of BIDs / proposals for production of concentrate of poppy straw & manufacture of Alkaloids
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Others
• Shri Nripendra Misra Principal Secretary to the Prime Minister of India
• Shri Nripendra Misra Principal Secretary to the Prime Minister of India
• Shri Nripendra Misra Principal Secretary to the Prime Minister of India
• Dr P.K. Mishra Additional Secretary to Prime Minister of India
• Shri K.A.P. Sinha Secretary to Government of Punjab
• Shri Rakesh Naithani Joint Director Rajya Sabha Secretariat
1 01.12.2014
2 07.04.2015
3 14.04.2015
4 03.06.2015
5 24.08.2015
Challenges facing the clinical research industry – over the last few years
OPPI position on the NLEM 2011
Revision of the NLEM 2011
Comments on Policy for Bioscience Sector 2015
Suggestions on the ‘Ease of Doing Business’ to the Sub-Committee of DRSC on Commerce
Date Subject Addressed to
62
With best compliments from
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Nehru Centre, Mumbai
Palladium Hotel, Mumbai
St. Regis, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
Club Peninsula
Date Programme Venue
Date Programme Venue
1 31.07.2015
2 07.08.2015
3 15.09.2015
Ethics & Compliance Conclave
Fourth Healthcare Access Summit
HR Summit: HR Imperatives for Organisational Sustainability
Interactive meeting: Ranjit Madan, Chief Executive Officer, Life Sciences Sector Skill Development Council (LSSSDC) with the Governance and Human Resource Management Committee
Presentation on New business models: operational efficiencies in the supply chain by Javin Bhinde, SynCore Consulting Group, to the Technical and Supply Chain Committee
Interaction of Healthcare Practitioners with the Ethics and Compliance WG
Presentation on Strategic levers for successful drug commercialization in India by Varun Gupta, Novartis, to the Finance and Taxation Committee
Presentation on the LSSSDC’s expectations from OPPI by KPMG, to the Governance and Human Resource Management Committee
Interactive meeting with KPMG on a study on the work done on CSR by OPPI members facilitated by the Access and Affordability WG
An interactive discussion between the E& Y Team led by Hitesh Sharma with the Finance and Taxation Committee on GST: impact, insight and way forward
Seminars and Knowledge Programmes
Seminars / Conferences
Knowledge Programmes
64
1 12.11.2014
2 27.11.2014
3 06.01.2015
4 08.01.2015
5 13.01.2015
6 14.01.2015
7 13.02.2015
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OPPI, Mumbai
Club Peninsula
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
OPPI, Mumbai
8 13.02.2015
9 02.03.2015
10 09.03.2015
11 10.03.2015
12 19.03.2015
13 31.03.2015
14 07.04.2015
15 10.04.2015
16 04.05.2015
17 12.05.2015
18 21.05.2015
20 19.06.2015
Presentation on Emergence of pan-India distributors and challenges to pharmaceutical companies by Ameesh Masurekar, Pharmatrack, AIOCD AWACS, to the Technical and Supply Chain Committee
Presentation on Union Budget by KPMG, to the OPPI members
Presentation on the Aarogya Bharat: India Healthcare Roadmap for 2025 by Bain & Company, to the Access and Affordability WG
Presentation on Building Contributors by V. Srinivas, Illumine Knowledge Resources, to the Governance and Human Resource Management Committee
Knowledge Session on the DPCO 2013 and the NPPP 2012 by Shirish Ghoge, Abbott Healthcare, conducted by the Finance and Taxation Committee
Interaction of NGOs with the Ethics and Compliance WG
Interactive session with Shweta Purandare, Secretary General, Advertising Standards Council of India (ASCI), organised by the Ethics and Compliance WG
Presentation on Electronic stock and sales system by Ameesh Masurekar, Pharmatrack, AIOCD AWACS, to the Technical and Supply Chain Committee
Interactive session with Shweta Purandare, Secretary General, ASCI, on the ASCI code and procedures on complaint handling, organised by Ethics and Compliance WG
Presentation on the various initiatives of LSSSDC by Ranjit Madan, CEO, LSSSDC, to the Governance and Human Resource Management Committee
Presentation on the Indian Accounting Standards converged with IFRS by Dinesh Jangid, KPMG, to the Finance and Taxation Committee
Presentation on If variable barcodes are made mandatory by Ameesh Masurekar, Pharmatrack, AIOCD AWACS, to the Technical and Supply Chain Committee
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BioAsia 2015: New era of Life Sciences, organised by BioAsia, Faba
Reinventing business for global excellence, organised by Theory of Constraints International Certification Organisation (TOCICO)
Making a mega brand, organised by Brand Dialogue
Managing risks & liabilities in the pharmaceutical food & beverages sectors, organised by the Bombay Chamber of Commerce and Industry
Workshop on Future of Health, organised by Futureworlds
Knowledge Session on Conducting clinical trials in India by Amita Bhave, Novartis, conducted by the Legal Committee
Knowledge Session on 2015 Asia-Pacific market trends/insights for the pharmaceuticals & life sciences sector by Ashish Ambasta, Watson India, Governance and Human Resource Management Committee
Genome Valley, Hyderabad
Jaypee Golf Resorts & Spa, Greater Noida
Hyatt Regency, Mumbai
Vivanta by Taj President, Mumbai
Royal Bombay Yacht Club, Mumbai
OPPI, Mumbai
MSD Office, Mumbai
Date Programme Venue
1 02.02.2015 03.02.2015 & 04.02.2015
2 18.04.2015 & 19.04.2015
3 08.05.2015
4 17.06.2015
5 28.07.2015
21 10.07.2015
22 21.08.2015
Events Supported by OPPI
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Name Member company Year
Late Dr H.R. Nanji Pharmed 1966
Keith C. Roy Merck Sharp Dohme 1967 - 1969
Late Brig. B. S. Bhagat Rallis 1970 - 1973
S.V. Pillai Pfizer 1974 - 1975
Late Mr Sisir Mitra Cyanamid 1976 - 1978
Late Mr H.N. Dutt Gupta East India Pharmaceutical Works 1979
Late Dr S.K. Bhattacharya Sandoz 1980 - 1981
Late Mr George Daniel Hoechst 1982 - 1984
R.N. Langrana Abbott 1985
C.M. Hattangdi Parke - Davis 1986 - 1987
Dr S. Agarwala Rallis 1988 - 1990
D.K. Bose Burroughs Wellcome 1990 - 1992
H. Dhanrajgir Glaxo 1992 - 1994
Dr Anil S. Mehta Wyeth 1994 - 1996
D. Bhadury Hoechst Marion Roussel 1996 - 1998
H.R. Khusrokhan Glaxo 1998 - 2000
Late Mr P. Gupta Infar 2000 - 2001
Tapan Ray Abbott Sept. - Nov. 2001
Ranjit Shahani Novartis 2001 - 2007
Ranga Iyer Wyeth 2007 - 2009
Ranjit Shahani Novartis 2009 - 2013
OPPI Past Presidents
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Organisation of Pharmaceutical Producers of IndiaMumbai: Peninsula Chambers, Ground Floor, Peninsula Corporate Park, Ganpatrao Kadam Marg,
Lower Parel, Mumbai 400 013. Tel: +91 22 2491 8123, +91 22 6662 7007 Delhi: Level 2, Elegance Building, Mathura Road, Jasola, New Delhi 110 025. Tel: +91 11 6635 1083
www.indiaoppi.com
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